Steerable delivery catheter

ABSTRACT

Tools and methods are provided for delivering a device to a native valve of a patient&#39;s heart. A catheter can include a flexible tube, a plurality of links, and a control wire. Applying tension to the control wire pulls on the links, which causes links to bend the flexible tube.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/984,661 titled “DEPLOYMENT SYSTEMS, TOOLS, AND METHODS FORDELIVERING AN ANCHORING DEVICE FOR A PROSTHETIC VALVE, filed on May 21,2018, which is a continuation of PCT Patent Application Serial No.PCT/US2017/066854 titled “DEPLOYMENT SYSTEMS, TOOLS, AND METHODS FORDELIVERING AN ANCHORING DEVICE FOR A PROSTHETIC VALVE” filed on Dec. 15,2017, which claims the benefit of U.S. Provisional Patent ApplicationSer. No. 62/435,563, filed on Dec. 16, 2016, and titled “DEPLOYMENTTOOLS AND METHODS FOR DELIVERING AN ANCHORING DEVICE FOR A PROSTHETICVALVE AT A NATIVE VALVE ANNULUS,” all of which are incorporated hereinby reference in their entireties.

FIELD

The present disclosure generally concerns deployment tools fordelivering anchoring devices, such as prostheses docking devices thatsupport prostheses and methods of using the same. For example, thedisclosure relates to replacement of heart valves that havemalformations and/or dysfunctions, where a flexible delivery catheter isutilized to deploy anchoring devices that support a prosthetic heartvalve at an implant site, and methods of using the delivery catheter toimplant such anchoring devices and/or prosthetic heart valves.

BACKGROUND

Referring generally to FIGS. 1A-1B, the native mitral valve 50 controlsthe flow of blood from the left atrium 51 to the left ventricle 52 ofthe human heart and, similarly, the tricuspid valve 59 controls the flowof blood between the right atrium 56 and the right ventricle 61. Themitral valve has a different anatomy than other native heart valves. Themitral valve includes an annulus made up of native valve tissuesurrounding the mitral valve orifice, and a pair of cusps or leafletsextending downward from the annulus into the left ventricle. The mitralvalve annulus can form a “D” shaped, oval shaped, or otherwisenon-circular cross-sectional shape having major and minor axes. Ananterior leaflet can be larger than a posterior leaflet of the valve,forming a generally “C” shaped boundary between the abutting free edgesof the leaflets when they are closed together.

When operating properly, the anterior leaflet 54 and the posteriorleaflet 53 of the mitral valve function together as a one-way valve toallow blood to flow from the left atrium 51 to the left ventricle 52.After the left atrium receives oxygenated blood from the pulmonaryveins, the muscles of the left atrium contract and the left ventriclerelaxes (also referred to as “ventricular diastole” or “diastole”), andthe oxygenated blood that is collected in the left atrium flows into theleft ventricle. Then, the muscles of the left atrium relax and themuscles of the left ventricle contract (also referred to as “ventricularsystole” or “systole”), to move the oxygenated blood out of the leftventricle 52 and through the aortic valve 63 and the aorta 58 to therest of the body. The increased blood pressure in the left ventricleduring ventricular systole urges the two leaflets of the mitral valvetogether, thereby closing the one-way mitral valve so that blood cannotflow back into the left atrium. To prevent or inhibit the two leafletsfrom prolapsing under the pressure and folding back through the mitralannulus toward the left atrium during ventricular systole, a pluralityof fibrous cords 62 called chordae tendineae tether the leaflets topapillary muscles in the left ventricle. The chordae tendineae 62 areschematically illustrated in both the heart cross-section of FIG. 1A andthe top view of the mitral valve in FIG. 1B.

Problems with the proper functioning of the mitral valve are a type ofvalvular heart disease. Vascular heart disease can affect the otherheart valves as well, including the tricuspid valve. A common form ofvalvular heart disease is valve leak, also known as regurgitation, whichcan occur in various heart valve, including both the mitral andtricuspid valves. Mitral regurgitation occurs when the native mitralvalve fails to close properly and blood flows back into the left atriumfrom the left ventricle during ventricular systole. Mitral regurgitationcan have different causes, such as leaflet prolapse, dysfunctionalpapillary muscles, problems with chordae tendineae, and/or stretching ofthe mitral valve annulus resulting from dilation of the left ventricle.In addition to mitral regurgitation, mitral narrowing or stenosis isanother example of valvular heart disease. In tricuspid regurgitation,the tricuspid valve fails to close properly and blood flows back intothe right atrium from the right ventricle.

Like the mitral and tricuspid valves, the aortic valve is likewisesusceptible to complications, such as aortic valve stenosis or aorticvalve insufficiency. One method for treating aortic heart diseaseincludes the use of a prosthetic valve implanted within the nativeaortic valve. These prosthetic valves can be implanted using a varietyof techniques, including various transcatheter techniques. Atranscatheter heart valve (THV) can be mounted in a crimped state on theend portion of a flexible and/or steerable catheter, advanced to theimplantation site in the heart via a blood vessel connected to theheart, and then expanded to its functional size, for example, byinflating a balloon on which the THV is mounted. Alternatively, aself-expanding THV can be retained in a radially compressed state withina sheath of a delivery catheter, where the THV can be deployed from thesheath, which allows the THV to expand to its functional state. Suchdelivery catheters and techniques of implantation are generally moredeveloped for implantation or use at the aortic valve, but do notaddress the unique anatomy and challenges of other valves.

SUMMARY

This summary is meant to provide some examples and is not intended to belimiting of the scope of the invention in any way. For example, anyfeature included in an example of this summary is not required by theclaims, unless the claims explicitly recite the features. Also, thefeatures described can be combined in a variety of ways. Variousfeatures and steps as described elsewhere in this disclosure may beincluded in the examples summarized here.

Tools and methods are provided for delivering a device to a native valveof a patient's heart. In one exemplary embodiment, a catheter caninclude a flexible tube, a plurality of links, and a control wire.Applying tension to the control wire causes the plurality of links tobend the flexible tube.

In one exemplary embodiment, a delivery catheter for delivering a deviceto a native valve of a patient's heart includes a flexible tube, aplurality of links, and a control wire. The flexible tube can include amain lumen and a control wire lumen. The plurality of links can bedisposed in the distal region of the flexible tube. Each link is alignedwith and connected to at least one adjacent link with a slot formedbetween each pair of adjacent links. A top portion of each link isnarrower than a bottom portion of each link when the links are viewedfrom a side. The control wire is in the control wire conduit and isconnected to the plurality of links. Applying tension to the controlwire causes the distal region of the flexible tube to bend.

In one exemplary embodiment, a delivery catheter for delivering a deviceto a native valve of a patient's heart includes a flexible tube, a firstring, a second ring, a plurality of links, a control wire, and a coilsleeve. The flexible tube can have a main lumen and a control wirelumen. A first ring is in a distal region of the flexible tube. A secondring is in the distal region of the flexible tube that is spaced apartfrom the first ring. A control wire is in the control wire conduit thatis connected to the first ring. A plurality of links are disposed in thedistal region of the flexible tube between the first ring and the secondring. A coil sleeve is disposed in the control wire lumen around thecontrol wire. The coil sleeve extends proximally from the distal regionof the flexible tube such that a portion of the control wire thatextends from the second ring to the first ring is not covered by thecoil sleeve. Applying tension to the control wire causes the distalregion of the flexible tube to bend.

In one exemplary method of making a flexible catheter tube, a flat sheetis provided. A plurality of spaced apart aligned cutouts are cut in tothe sheet. Each cutout has a central portion between two end portions. Awidth of the central portion of each cutout is wider than the width ofthe two end portions of each cutout. The cutouts form a correspondingplurality of spaced apart aligned strips each having a central portionand two end portions. A width of the central portion of strip isnarrower than the width of the two end portions of strip. The sheet isrolled into a substantially cylindrical shape having a plurality oflinks with a slot formed between each pair of adjacent links. Topportions of the links correspond to the central portions of the stripsand bottom portions of the links correspond to the end portions of thestrips.

The tools and methods summarized here can also include any of thefeatures, components, elements, etc. described elsewhere in thisdisclosure, and the methods summarized here can also include any of thesteps described elsewhere in this disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features, and advantages of theinvention will become more apparent from the following detaileddescription using the accompanying figures. In the drawings:

FIG. 1A shows a schematic cross-sectional view of a human heart;

FIG. 1B shows a schematic top view of the mitral valve annulus of aheart;

FIG. 2A shows a perspective view of an exemplary anchoring device thatis helical;

FIG. 2B shows a partial perspective view of a an exemplary deliverydevice for implanting the anchoring device at a native valve of a heart,using a transseptal technique;

FIG. 2C shows a cross-sectional view of the anchoring device and anexemplary prosthetic heart valve implanted at the native valve of theheart;

FIG. 3A shows a perspective view of an exemplary distal section of adelivery catheter used as part of an exemplary delivery device forimplanting an anchoring device;

FIG. 3B is a cross-sectional view of several links of the distal sectionof FIG. 3A;

FIG. 4 is a perspective view of the distal section of the deliverycatheter in a bent or curved configuration;

FIG. 5 is a flat view of an exemplary laser cut sheet that can be usedfor forming a distal section of a delivery catheter;

FIG. 6 is a flat view of another exemplary laser cut sheet that can beused for forming a distal section of a delivery catheter;

FIG. 7 is a flat view of another exemplary laser cut sheet that can beused for forming a distal section of a delivery catheter;

FIG. 8 shows a perspective view of a bent or curved configuration of adistal section of a delivery catheter usable for implanting an anchoringdevice at a native valve, e.g., using a transseptal technique;

FIG. 9A is a side cutout view of a portion of a patient's heart thatillustrates an exemplary delivery device entering the left atriumthrough the fossa ovalis in an exemplary method;

FIG. 9B illustrates the delivery device of FIG. 9A entering the leftatrium of the patient's heart in the position shown in FIG. 9A, in whichthe delivery device is shown from a view taken along the lines B-B inFIG. 9A;

FIG. 9C illustrates the delivery device of FIG. 9A in a second position;

FIG. 9D illustrates the delivery device of FIG. 9A in the secondposition shown in FIG. 9C, in which the delivery device is shown from aview taken along the lines D-D in FIG. 9C;

FIG. 9E illustrates the delivery device of FIG. 9A in a third position;

FIG. 9F illustrates the delivery device of FIG. 9A in the third positionshown in FIG. 9E, in which the delivery device is shown from a viewtaken along the lines F-F in FIG. 9E;

FIG. 9G illustrates the delivery device of FIG. 9A in a fourth position;

FIG. 9H illustrates the delivery device of FIG. 9A in the fourthposition shown in FIG. 9G, in which the delivery device is shown from aview taken along the lines H-H in FIG. 9G;

FIG. 9I is a side cutout view of the left side of a patient's heart thatillustrates a an anchoring device being delivered around the chordaetendineae and leaflets in the left ventricle of the patient's heart;

FIG. 9J illustrates the anchoring device of FIG. 9I further wrappingaround the chordae tendineae and leaflets in the left ventricle of thepatient's heart as it is being delivered by the delivery device of FIG.9A;

FIG. 9K illustrates the anchoring device of FIG. 9I further wrappingaround the chordae tendineae and leaflets in the left ventricle of thepatient's heart as it is being delivered by the delivery device of FIG.9A;

FIG. 9L is a view looking down into the patient's left atrium,illustrating the delivery device of FIG. 9A, after the anchoring deviceof FIG. 9I is wrapped around the chordae tendineae and leaflets in theleft ventricle of the patient's heart;

FIG. 9M illustrates the delivery device of FIG. 9A in the left atrium ofthe patient's heart, in which the delivery device is retracting todeliver a portion of the anchoring device in the left atrium of thepatient's heart;

FIG. 9N illustrates the delivery device of FIG. 9A in the left atrium ofthe patient's heart, in which the delivery device is retracting todeliver a further portion of the anchoring device in the left atrium ofthe patient's heart;

FIG. 9O illustrates the delivery device of FIG. 9A in the left atrium ofthe patient's heart, in which the anchoring device is exposed and shownconnected tightly to a pusher in the left atrium of the patient's heart;

FIG. 9P illustrates the delivery device of FIG. 9A in the left atrium ofthe patient's heart, in which the anchoring device is fully removed fromthe delivery device and is loosely and removably attached to the pusherby a suture;

FIG. 9Q is a cutout view of the patient's heart that illustrates anexemplary embodiment of a prosthetic heart valve being delivered by anexemplary embodiment of a heart valve delivery device to the mitralvalve of the patient;

FIG. 9R illustrates the heart valve of FIG. 9Q being further deliveredto the mitral valve of the patient by the heart valve delivery device;

FIG. 9S illustrates the heart valve of FIG. 9Q being opened by inflationof a balloon to expand and attach the heart valve to the mitral valve ofthe patient;

FIG. 9T illustrates the heart valve of FIG. 9Q attached to the mitralvalve of the patient's heart and secured by the anchoring device of FIG.9I;

FIG. 9U is an upward view of the mitral valve from the left ventriclethat illustrates the prosthetic heart valve of FIG. 9Q attached to themitral valve of the patient's heart from a view taken along the linesU-U in FIG. 9T;

FIG. 10 shows a perspective view of a spiral configuration of a distalsection of a delivery catheter that can be used for implanting ananchoring device at a native valve, which can optionally be used duringa transseptal technique;

FIG. 11 shows a perspective view of a hybrid configuration of a distalsection of a delivery catheter that can be used for implanting ananchoring device at a native valve, which can optionally be used duringa transseptal technique;

FIG. 12 shows a partial perspective view of an exemplary delivery devicethat can be used for implanting an anchoring device at a native mitralvalve, e.g., using another transseptal technique;

FIG. 13 shows a schematic side view of an exemplary distal section of adelivery catheter with an exemplary two control wire or pull wire systemthat can be used in various delivery catheters or delivery devicesherein;

FIG. 14 shows a cross-sectional view of a multi-lumen extrusion portionof the delivery catheter of FIG. 13, the cross-section taken in a planeperpendicular to a longitudinal axis of the delivery catheter;

FIG. 15 shows a schematic perspective view of the delivery catheter ofFIGS. 13-14 in a partially actuated state;

FIG. 16 shows a schematic perspective view of the delivery catheter ofFIGS. 13-15 in a fully actuated state;

FIGS. 17A-17C show perspective views of an exemplary lock or lockingmechanism for an anchoring device;

FIG. 17D is a cross-sectional view of the lock or locking mechanism ofFIGS. 17A-17C;

FIGS. 18A-18C show perspective views of another exemplary lock orlocking mechanism for an anchoring device according to one embodiment;and

FIG. 19 shows a perspective view of an exemplary distal section of adelivery catheter usable as part of the delivery device for implantingan anchoring device;

FIG. 20A is an end view of another exemplary embodiment of a deliverycatheter;

FIG. 20B is a sectional view taken along the plane indicated by linesB-B in FIG. 20A;

FIG. 20C is a sectional view taken along the plane indicated by linesC-C in FIG. 20C;

FIG. 20D is a sectional view taken along the plane indicated by linesD-D in FIG. 20C:

FIG. 20E is a sectional view taken along the plane indicated by linesE-E in FIG. 20C;

FIG. 21A shows a schematic perspective view of a distal section of thedelivery catheter of FIGS. 20A-20E in a partially actuated state;

FIG. 21 B shows a schematic perspective view of the distal section ofthe delivery catheter of FIGS. 20A-20E in a more actuated state;

FIG. 22A is a partial view of the delivery catheter of FIGS. 20A-20E;

FIGS. 22B-22D show cross-sectional views of the delivery catheter shownin FIG. 22A, the cross-sections taken in a plane perpendicular to alongitudinal axis of the delivery catheter; and

FIG. 23 shows a schematic view of an exemplary two pull wire system forthe delivery catheter shown in FIGS. 20A-20E.

DETAILED DESCRIPTION

The following description and accompanying figures, which describe andshow certain embodiments, are made to demonstrate, in a non-limitingmanner, several possible configurations of systems, devices,apparatuses, components, methods, etc. that may be used for variousaspects and features of the present disclosure. As one example, varioussystems, devices/apparatuses, components, methods, etc. are describedherein that may relate to mitral valve procedures. However, specificexamples provided are not intended to be limiting, e.g., the systems,devices/apparatuses, components, methods, etc. can be adapted for use inother valves beyond the mitral valve (e.g., in the tricuspid valve).

Described herein are embodiments of deployment tools that are intendedto facilitate implantation of prosthetic devices (e.g., prostheticvalves) at one of the native mitral, aortic, tricuspid, or pulmonaryvalve regions of a human heart, as well as methods for using the same.The prosthetic devices or valves can be expandable transcatheter heartvalves (“THVs”) (e.g., balloon expandable, self-expandable, and/ormechanically expandable THVs). The deployment tools can be used todeploy anchoring devices (sometimes referred to as docking devices,docking stations, or similar terms) that provide a more stable dockingsite to secure the prosthetic device or valve (e.g., THVs) at the nativevalve region. These deployment tools can be used to more accuratelyplace such anchoring devices (e.g., prostheses anchoring devices,prosthetic valve anchoring device, etc.), so that the anchoring devicesand any prostheses (e.g., prosthetic devices or prosthetic heart valves)anchored thereto function properly after implantation.

An example of one such anchoring device is shown in FIG. 2A. Otherexamples of anchoring devices that can be used herein are shown in U.S.patent application Ser. Nos. 15/643,229, 15/684,836, and 15/682,287,which are each incorporated by reference in their entirety herein. Theanchoring devices herein can be coiled or helical or they can includeone or more coiled or helical regions. Anchoring device 1 is shown inFIG. 2A as including two upper coils 10 a, 10 b and two lower coils 12a, 12 b. In alternative embodiments, the anchoring device 1 can includeany suitable number of upper coils and lower coils. For example, theanchoring device 1 can include one upper coil, two or more upper coils,three or more upper coils, four or more upper coils, five or more uppercoils, etc. In addition, the anchoring device 1 can have one lower coil,two or more lower coils, three or more lower coils, four or more lowercoils, five or more lower coils, etc. In various embodiments, theanchoring device 1 can have the same number of upper coils as it haslower coils. In other embodiments, the anchoring device 1 can have moreor less upper coils as compared to lower coils.

Anchoring devices can include coils/turns of varying diameters or thesame diameters, coils/turns spaced with varying gap sizes or no gaps,and coils/turns which taper, expand, or flare to become larger orsmaller. It should be noted that the coils/turns can also stretchradially outward when a prosthetic valve is placed or expanded withinanchoring device 1.

In the illustrated embodiment of FIG. 2A, the upper coils 10 a, 10 b canbe about the same size as or can have a slightly smaller diameter thanthe lower coils 12 a, 12 b. One or more lower end coils/turns (e.g., afull or partial end coil/turn) can have a larger diameter or largerradius of curvature than other coils and act as an encircling coil/turnto help guide the end of the coil outside and around the leaflets and/orany chordae tendineae, e.g., to encircle and corral the leaflets and/orany chordae tendineae. One or more larger-diameter or larger-radiuslower coils or encircling coils allow for easier engagement with thenative valve annulus and navigation around the native valve anatomyduring insertion.

In some embodiments, one or more upper coils/turns (e.g., full orpartial coils/turns) can be larger or have a larger diameter (or radiusof curvature) and act as a stabilization coil (e.g., in an atrium of theheart) to help hold the coil in position before the prosthetic valve isdeployed therein. In some embodiments, the one or more upper coils/turnscan be atrial coils/turns and can have a greater diameter than the coilsin the ventricle, for example, acting as a stabilization coil/turnconfigured to engage an atrial wall for stability.

Some of the coils can be functional coils (e.g., coils/turns between thestabilization coil(s)/turn(s) and the encircling coil(s)/turn(s)) inwhich the prosthetic valve is deployed and forces between the functionalcoils and prosthetic valve help to hold each other in position. Theanchoring device and prosthetic valve may pinch native tissue (e.g.,leaflets and/or chordae) between themselves (e.g., between thefunctional coils of the anchoring device and an outer surface of theprosthetic valve) to more securely hold them in place.

In one embodiment, which can be the same as or similar to the anchoringdevice shown in FIGS. 9I-9U, an anchoring device has one large uppercoil/turn or stabilization coil/turn, one lower end coil/turn orencircling coil/turn, and multiple functional coils/turn (e.g., 2, 3, 4,5, or more functional coils/turns).

When used at the mitral position, the anchoring device can be implantedso that one or more upper coils/turns (e.g., the upper coils 10 a, 10 b)are above, i.e., on the atrial side, of the annulus of the native valve(e.g., mitral valve 50 or a tricuspid valve) and the lower coils 12 a,12 b are below, i.e., on the ventricular side, of the annulus of thenative valve, for example, as shown in FIG. 2C. In this configuration,the mitral leaflets 53, 54 can be captured between the upper coils 10 a,10 b and the lower coils 12 a, 12 b. When implanted, the variousanchoring devices herein can provide a solid support structure to securea prosthetic valve in place and avoid migration due to the operation ofthe heart.

FIG. 2B shows a general delivery device 2 for installing an anchoringdevice at a native mitral valve annulus 50 using a transseptaltechnique. The same or a similar delivery device 2 could be used todelivery an anchoring device at the tricuspid valve without having toleave the right atrium to cross the septum into the left atrium. Thedelivery device 2 includes an outer sheath or guide sheath 20 and aflexible delivery catheter 24. The sheath 20 has a shaft in the shape ofan elongated hollow tube through which the delivery catheter 24, as wellas various other components (e.g., the anchoring device, a prostheticheart valve, etc.), can pass, thus allowing the components to beintroduced into the patient's heart 5. The sheath 20 can be steerable sothat the sheath 20 can be bent at various angles needed for the sheathto pass through the heart 5 and enter the left atrium 51. While in thesheath 20, the delivery catheter 24 is in a relatively straight orstraightened configuration (compared to a bent configuration discussedin greater detail below), e.g., the delivery catheter 24 is held insheath 20 in a configuration or shape that corresponds to theconfiguration or shape of the sheath 20.

Like the sheath 20, the delivery catheter 24 has a shaft having theshape of an elongated hollow tube. However, the delivery catheter 24 hasa smaller diameter than the sheath 20 so that it can slide axiallywithin the sheath 20. Meanwhile, the delivery catheter 24 is largeenough to house and deploy an anchoring device, such as the anchoringdevice 1.

The flexible delivery catheter 24 also has a flexible distal section 25.The distal section 25 can bend into a configuration that allows for moreaccurate placement of the anchoring device 1, and in general should havea robust design that allows for the distal section 25 to be bent andheld at such configuration. For example, as shown in FIG. 2B, theflexible distal section 25 can bend into a curved configuration in whichthe distal section 25 is curved to assist in extrusion or pushing out ofthe anchoring device 1 on a ventricular side of the mitral valve 50, sothat the lower coils (e.g., functional coils and/or encircling coils) ofthe anchoring device 1 can be properly installed below the annulus ofthe native valve. The flexible distal section 25 can also be bent intothe same or in a different curved configuration so that the uppercoil(s) (e.g., a stabilization coil/turn or upper coils 10 a, 10 b) ofthe anchoring device can be accurately deployed on the atrial side ofthe annulus of the native valve. For example, the flexible distalsection 25 can have the same configuration for installing the uppercoils 10 a, 10 b as is used for installing the lower coils 12 a, 12 b.In other embodiments, the flexible distal section 25 can have oneconfiguration for installing the lower coils 12 a, 12 b and anotherconfiguration for installing the upper coils 10 a, 10 b. For example,the flexible distal section 25 can be axially translated backwards fromthe position described above for releasing the lower coils 12 a, 12 b torelease and position the upper coils 10 a, 10 b on the atrial side ofthe annulus of the native valve.

In use, when using a transseptal delivery method to access the mitralvalve, the sheath 20 can be inserted through a femoral vein, through theinferior vena cava 57 and into the right atrium 56. Alternatively, thesheath 20 can be inserted through a jugular vein or subclavian vein orother upper vasculature location and passed through the superior venacava and into the right atrium. The interatrial septum 55 is thenpunctured (e.g., at the fossa ovalis) and the sheath 20 is passed intothe left atrium 51, as can be seen in FIG. 2B. (In tricuspid valveprocedures, it is unnecessary to puncture or cross the septum 55.) Thesheath 20 has a distal end portion 21, which can be a steerable orpre-curved distal end portion to facilitate steering of the sheath 20into the desired chamber of the heart (e.g., the left atrium 51).

In mitral valve procedures, with the sheath 20 in position in the leftatrium 51, the delivery catheter 24 is advanced from the distal end 21of the sheath 20, such that the distal section 25 of the deliverycatheter 24 is also in the left atrium 51. In this position, the distalsection 25 of the delivery catheter 24 can be bent or curved into one ormore curved or activated configuration(s) to allow for an anchoringdevice 1 to be installed at the annulus of the mitral valve 50. Theanchoring device 1 can then be advanced through the delivery catheter 24and installed at the mitral valve 50. The anchoring device 1 can beattached to a pusher that advances or pushes the anchoring device 1through the delivery catheter 24 for implantation. The pusher can be awire or tube with sufficient strength and physical characteristics topush the anchoring device 1 through the delivery catheter 24. In someembodiments, the pusher can be made of or include a spring or coil(e.g., see flexible tubes 87, 97 in FIGS. 17A-18C below), a tubeextrusion, a braided tube, or a laser cut hypotube, among otherstructures. In some embodiments, the pusher can have a coating overand/or inside it, e.g., it can have an interior lumen lined by PTFE toallow a line (e.g., a suture) to be atraumatically actuated through thelined lumen. As noted above, in some embodiments, after the pusher haspushed and properly positioned the ventricular coils of the anchoringdevice 1 in the left ventricle, the distal section 25 can, for example,be axially translated backwards to release the atrial coils of theanchoring device 1 into the left atrium, while maintaining or holding aposition of the ventricular coils of the anchoring device 1 within theleft ventricle.

Once the anchoring device 1 is installed, the delivery catheter 24 canbe removed by straightening or reducing the curvature of the flexibledistal section 25 to allow the delivery catheter 24 to pass back throughthe sheath 20. With the delivery catheter 24 removed, a prostheticvalve, for example, a prosthetic transcatheter heart valve (THV) 60 canthen be passed, for example, through the sheath 20 and secured withinthe anchoring device 1, as shown for example in FIG. 2C. When the THV 60is secured within the anchoring device 1, the sheath 20 along with anyother delivery apparatuses for the THV 60 can then be removed from thepatient's body and the openings in the patient's septum 55 and rightfemoral vein can be closed. In other embodiments, after the anchoringdevice 1 has been implanted, a different sheath or different deliverydevice altogether can be separately used to deliver the THV 60. Forexample, a guide wire can be introduced through sheath 20, or the sheath20 can be removed and the guide wire can be advanced via the same accesspoint, through the native mitral valve, and into the left ventricle,using a separate delivery catheter. Meanwhile, even though the anchoringdevice is implanted trans-septally in this embodiment, it is not limitedto transseptal implantation, and delivery of the THV 60 is not limitedto transseptal delivery (or more generally via the same access point asdelivery of the anchoring device). In still other embodiments, aftertransseptal delivery of the anchoring device 1, any of various otheraccess points can thereafter be used to implant the THV 60, for example,trans-apically, trans-atrially, or via the femoral artery.

FIG. 3A shows a perspective view of an exemplary distal section 25 thatcan be used in a delivery catheter 24. The distal section includes twoopposite ends, two opposite sides 26 & 27, a top 28, and a bottom 29extending between the two ends. These have been labelled for ease ofdescription and understanding and are not intended to limit theorientation of the distal section 25. The distal section 25 of FIG. 3Aforms a generally cylindrical hollow tube that can include a pluralityof links 38. Each link 38 has the shape of a cylindrical segment andeach link 38 is aligned with and connected to adjacent links 38 to formthe cylindrical tube shape of the distal section 25. While the distalsection 25 is cylindrical in this embodiment, other shapes, such asovular distal sections, are also possible. Each link 38 of the distalsection 25 can have a greater width at the bottom 29 than at the top 28,giving the links 38 the general shape of an acute trapezoid when viewedfrom the side, as best seen in FIG. 3B. The bottom of each link 38 canhave slits 39 to allow for more flexing of the links 38 relative to oneanother.

The distal section 25 can include a double guiding pattern forming ahybrid bending section that incorporates both side teeth 31, 32 and topteeth 33. To this effect, each link 38 can include two side teeth 31, 32on opposite sides of the link 38 and a top tooth 33. With respect to thedistal section 25, the two rows of side teeth 31, 32 of the links 38 canrun the length of the sides 26, 27 of the distal section 25,respectively, and the top teeth 33 can run the length of the distalsection 25 on the top 28, as best seen in FIG. 3A. While the rows ofside teeth 31, 32 and top teeth 33 are shown to run straight along thelength of the distal section 25 in this illustrated embodiment, otherembodiments can have different configurations. For example, in someembodiments, the rows of side teeth 31, 32 and top teeth 33 can spiralaround the tube of the distal section 25, for example, as shown in FIG.4, to effect specific bending shapes of the distal section 25 when thedistal section 25 is actuated. In certain embodiments, the side teeth31, 32 can be mirror images of each other to allow analogous bending onopposite sides 26, 27 of the distal section 25. In other embodiments,the side teeth 31, 32 can have different shapes and/or sizes incomparison to each other. The teeth 31, 32, 33 can take any othersuitable shape and/or size that allows the distal section 25 to move toa flexed configuration while delivering an anchoring device. While theteeth 31, 32, 33 are all right-facing teeth in the illustratedembodiment (e.g., directed to the right in the view shown in FIG. 3B),in other embodiments, the teeth can be left-facing teeth (see, forexample, FIG. 4) or the top and side teeth can face differentdirections, for example.

Adjacent to each side tooth 31, 32 and each top tooth 33 is acorresponding side slot or groove 34, 35 and top slot or groove 36,respectively, on an adjacent link 38. Each slot 34, 35, 36 can have ashape complementary to the side tooth 31, 32 or top tooth 33 to which itis adjacent. When the distal section 25 is in a straightenedconfiguration, the side teeth 31, 32 are partially inserted into theside slots 34, 35 and the top teeth 33 are separated from their adjacenttop slots 36 by a gap. Having the side teeth 31, 32 partially within theside slots 34, 35 in this straightened configuration provides additionaltorque resistance to the distal section 25 when the distal section 25 ofthe delivery catheter 24 is not fully flexed. However, in otherembodiments, the side teeth 31, 32 may not be positioned partiallywithin the side slots 34, 35 when the distal section 25 is in thestraightened configuration.

When the distal section 25 is bent, each side tooth 31, 32 moves furtherinto its corresponding side slot 34, 35 and each top tooth 33 movescloser to and then into its corresponding top slot 36. The addition ofthe top teeth 33 and top slots 36 provides enhanced torqueability andtorque resistance to the distal section 25 when it is in the fullyflexed configuration. Further, having both side teeth 31, 32 and topteeth 33 provides additional guiding control and structural support whenadjusting the distal section 25 from its straightened to its flexedconfiguration.

FIG. 3B is a detailed cross-sectional view of several links 38 of thedistal section 25 of FIG. 3A. While FIG. 3B is described with respect tothe side teeth 32, this description equally applies to side teeth 31 onthe opposite side of the distal section 25. Side teeth 32 are shown asbeing positioned along a tooth line 40 that is low relative to the top28 of the distal section 25. This positioning causes the side teeth 32to have a smaller displacement, i.e., the distance the side teeth 32move into the adjacent slot 35 is much shorter or less than if the sideteeth 32 were positioned closer to the top 28 of the distal section 25.For example, in the illustrated embodiment, the distance that the sideteeth 31, 32 move during flexing is smaller compared to the distancethat the top teeth 33 move. In other words, the top teeth 33 move agreater distance relative to adjacent links 38 when the distal section25 is adjusted to a fully bent configuration, as compared to the sideteeth 31, 32. This arrangement allows the use of shorter side teeth 31,32 (e.g., to have side teeth with shorter longitudinal lengths), whichcan in turn be incorporated into shorter bending sections in the distalsection 25.

Further, the low tooth line also provides more space for wider toothslots 34, 35 to accommodate, for example, even larger side teeth sincethe tooth slots 34, 35 are located at the wider lower portions of thelinks 38. Having more space to house larger and/or more appropriate orrobust tooth slots 34, 35 for the side teeth 31, 32 can enhance guidingof the teeth 31, 32 into the slots 34, 35, for example, during bending.The low tooth line also allows for the above discussed robust toothdesign that can still provide structural support while bending the linksaway from each other, i.e., in the opposite direction of the bendingconfiguration. Therefore, when bending the links away from each other,the side teeth can still maintain their interface with the adjacent sideslots, and this maintained tooth-slot interface can provide for morestructural support and torqueability.

FIG. 4 is a perspective view of a distal section 25′ in a bentconfiguration according to a modification of the first embodiment. Thedistal section 25′ in FIG. 4 is similar to the distal section 25 of FIG.3A, except that in FIG. 4, the rows of top teeth 33′ and the rows ofside teeth 31′, 32′ are shifted laterally around the tube-shaped distalsection 25′ instead of continuing in a straight line down the length ofthe distal section. This positioning of the rows of teeth 31′, 32′, 33′along, for example, a spiral line allows the distal section 25′ to bendin three dimensions, as opposed to a single plane as would occur in FIG.3A. As seen in FIG. 4, the example distal section 25′ has a threedimensional curved shape. Various embodiments of distal sections can belaser cut (e.g., into a sheet or tube) so that the top and side teethfollow a pattern that will form a desired shape during bending. Forexample, patterns can be cut that create a distal section having a bentshape that, when used in surgery, allows the distal section to bepositioned at the mitral or other valve, such that an anchoring devicecan be advanced from the distal section and accurately positioned at thevalve.

Distal sections 25, 25′ can be manufactured by cutting, for example, bylaser cutting a flat metal strip or sheet with the desired pattern andthen rolling the patterned metal strip or sheet into a hypotube.Alternatively, the desired pattern (e.g., the same or similar patternsto those shown in various figures herein) could be cut directly into atube (e.g., a hypotube) without using a sheet or having to roll thematerial. As an example, FIG. 5 shows a flat view of an exemplary lasercut file or sheet 30 that can be used for the distal section 25 of FIG.3A. This laser cut sheet 30 includes both the top teeth 33 and theirassociated slots 36 and the side teeth 31, 32 and their associated slots34, 35 arranged in straight rows along the length of the distal section25. However, as noted above, this laser cut file 30 can be modified tohave the teeth 31, 32, 33 and their associated slots 34, 35, 36 arrangedin other different paths or configurations, for example, in rows ofspiral lines, in order to create a curved or spiral bent distal section25′ similar to the one shown in FIG. 4. In other embodiments, variouspatterns can be cut that provide distal sections that can bend in othershapes or configurations that help accurately navigate and deploy ananchoring device into position at the implant site during surgery.

Many types of sheets capable of being folded into tubing can be used formaking the cut distal sections. Further many types of tubes can be cutinto the desired pattern(s). For example, Nitinol and stainless steelcan be used, as well as various other suitable metals known in the art,as materials for the sheets or tubes.

While the above embodiments include both top and side teeth, such thateach link 38 has three teeth total, other embodiments may only includeone of either the top or side teeth, or no teeth at all.

FIG. 6 is a flat view of another exemplary laser cut sheet 30″ for adistal section 25″ of a delivery catheter. The distal section 25″ ofFIG. 6 is similar to the distal section 25 of FIG. 5, however, links 38″of the distal section 25″ only include the two side teeth 31, 32 andtheir associated slots 34, 35, and do not include any top teeth orcorresponding slots.

FIG. 7 is a flat view of another exemplary laser cut sheet 30′″ for adistal section 25′″ of a delivery catheter. The distal section 25′″ ofFIG. 7 is also similar to the distal section 25 of FIG. 5, however, eachof the links 38′″ of the distal section 25′″ only includes the singletop tooth 33 and its associated slot 36 and do not include any sideteeth or corresponding slots.

In other embodiments, more or less than three teeth in any combinationcan be included on each link. Meanwhile, while FIGS. 6 and 7 are shownwith teeth arranged in straight rows along the length of the distalsections 25″, 25′″, respectively, the laser cut sheets 30″, 30′″ canalso be modified to include various tooth patterns and arrangements inorder to have distal sections capable of bending in specific desiredshapes, similarly as discussed above.

Various sheath and catheter designs can be used to effectively deploythe anchoring device at the implant site. For example, for deployment atthe mitral position, the delivery catheter can be shaped and/orpositioned to point towards commissure A3P3, so that a coil anchordeployed from the catheter can more easily enter the left ventricle andencircle the chordae 62 during advancement. However, while the variousexemplary embodiments of the invention described below are configured toposition the distal opening of the delivery catheter at commissure A3P3of the mitral valve, in other embodiments, the delivery catheter canapproach the mitral plane to point to, and the anchoring device can beadvanced through, commissure A1P1 instead. In addition, the catheter canbend either clockwise or counter-clockwise to approach either commissureof the mitral valve or a desired commissure of another native valve, andthe anchoring device can be implanted or inserted in a clockwise orcounter-clockwise direction (e.g., coils/turns of the anchoring devicecan turn in a clockwise or counter-clockwise direction depending on howthe anchoring device will be implanted).

In still further embodiments, the catheter itself can also be positionedto pass below a plane of the annulus of a native valve and sit in one ofthe commissures or to extend into a ventricle (e.g., through one of thecommissures). In some embodiments, the distal end of the catheter caneven be used to capture and/or corral some or all the chordae tendineae62. The catheter can be positioned in any suitable manner that allows ananchoring device to be deployed at an implant site. In some embodiments,the catheter itself can have an atraumatic tip design, to provideatraumatic access to the implant site, for example, by reducing oreliminating any damage that could potentially be caused by theadvancement and/or shape manipulation of the catheter while it ispositioned at the implant site.

While several of the above embodiments for the distal section of adelivery catheter include teeth and corresponding slots, otherembodiments for the distal section can include no teeth norcorresponding slots. FIG. 19 is a perspective view of another exemplarydistal section 25″″ that can be used for a delivery catheter. In thisembodiment, the distal section 25″″ is a solid, generally cylindricalhollow tube made from a flexible material. The flexible material can be,for example, nitinol, steel, and/or plastic, or any other suitablematerial or combination of materials that allow the distal section 25″″to be moved to a flexed configuration while delivering an anchoringdevice. While the illustrated embodiment shows the distal section 25″″being a generally cylindrical tube, it should be understood that, inalternative embodiments, the shape of the distal section 25′″ can takeany suitable form that is capable of delivering an anchoring device.Some embodiments of the distal section may include linear slits and/orrectangular windows.

FIG. 8 shows a perspective view of a curved configuration or a “hockeystick” configuration of a distal section 65 of a delivery catheter 64.This configuration can be used for implanting an anchoring device at anative valve (e.g., at a native mitral valve using, for example, atransseptal technique). In the “hockey stick” configuration, the distalend 65 of the delivery catheter 64 extending from a transseptal sheath20 has four main subsections: a first flexing section that forms ashallow curved portion 66, a second flexing section that forms acircular or curved planar portion 67, a turn 68 and a flexible endportion 69. The shapes of these subsections allow the distal section 65to navigate the delivery catheter 64 into position at a native valve(e.g., a native mitral valve) and accurately deploy an anchoring deviceat the native valve (e.g., at the mitral position). The distal section65 can take any suitable form that allows the distal section to take theflexed configuration described above, such as, for example, any formdescribed in the present application. While, in the illustratedembodiment, the distal section 65 of the delivery catheter 64 curves ina clockwise direction, in other embodiments (for example, as seen in theembodiment in FIGS. 9A-9U), the distal section 65 can instead curve inan opposite, counter-clockwise direction, e.g., at circular/curvedplanar portion 67 and/or turn 68.

FIGS. 9A-9U illustrate another exemplary embodiment of a delivery device(which can be the same as or similar to other anchoring devicesdescribed herein) delivering and implanting an anchoring device (whichcan be the same as or similar to other anchoring devices describedherein) at a native valve of a patient (e.g., at the native mitral valve50 of a patient using a transseptal technique). FIG. 9A is a cutout viewof the left atrium of a patient's heart that illustrates a sheath 20(e.g., a guide sheath or transseptal sheath) passing through theinteratrial septum, which can happen at the fossa ovalis (FO), and intothe left atrium, and a delivery catheter 64 extending from the sheath20. FIG. 9B illustrates the transseptal sheath 20 and the deliverycatheter 64 in the position shown in FIG. 9A from a view looking down atthe mitral valve 50 from the left atrium 51 (i.e., from a view takenalong the line B-B in FIG. 9A). Referring to FIG. 9A, the sheath 20enters the left atrium such that the sheath is substantially parallelwith the plane of the mitral valve 50. The sheath 20 and deliverycatheter 64 can take any suitable form, such as, for example, any formdescribed in the present application.

In some embodiments, the sheath 20 can be actuated or steerable so thatthe sheath 20 can be positioned or bent until it makes an angle (e.g., a30-degree angle or an approximately 30-degree angle) with respect to theseptum and/or FO wall. In some embodiments, the angle orientation (e.g.,30-degree angle orientation) can be adjusted or controlled by rotatingor further actuating the sheath 20, and can be adjusted to bettercontrol the orientation at which the delivery catheter 64 enters theleft atrium. In other embodiments, the deflection angle of the sheath 20relative to the septum and/or FO can be either more or less than 30degrees, depending on each situation, and in some applications, can evenbe oriented at or bent to be 90 degrees relative to the septum and/orFO. In certain embodiments, the deflection angle of the sheath can bemoved between about 0 degrees and about 90 degrees, such as, forexample, between about 5 degrees and about 80 degrees, such as betweenabout 10 degrees and 70 degrees, such as between about 15 degrees andabout 60 degrees, such as between about 20 degrees and about 50 degrees,such as between about 25 degrees and about 40 degrees, such as betweenabout 27 degrees and about 33 degrees.

Referring to FIGS. 9C-9D, after the outer sheath or guide sheath 20passes through the septum and/or FO and is placed in a desired position,the delivery catheter 64 exits and extends from the sheath 20. Thedelivery catheter is controlled such that the delivery catheter includesa distal end 65 having a circular or curved planar portion 67. In theillustrated embodiment, the distal end 65 of the delivery catheter 64 ismoved such that the distal end 65 curves in a counter-clockwisedirection to create the circular/curved planar portion 67 (the anchoringdevice can also coil in a counter-clockwise direction). In alternativeembodiments, the distal end 65 is moved such that the distal end 65curves in the clockwise direction to create the circular/curved planarportion 67 (in these embodiments the anchoring device can also coil in aclockwise direction).

Referring to FIGS. 9E-9F, the delivery catheter 64 is also extendeddownward by a shallow curved portion 66 of the distal end 65. As shownin FIG. 9E, the delivery catheter 64 is extended downward until thecircular/curved planar portion 67 of the distal end 65 nears the planeof the mitral valve 50, which is generally about 30 to 40 mm below theFO wall. In some situations, however, the plane of the mitral valve maybe less than 30 mm below the FO or more than 30 mm below the FO. Incertain embodiments, the delivery catheter 64 is configured to extend 60mm or less from the outer sheath, such as, for example, 50 mm or less,such as 45 mm or less, such as 40 mm or less, such as 35 mm or less,such as 30 mm or less, such as 25 mm or less, such as 20 mm or less. Insome embodiments, the maximum extension of the delivery catheter 64 fromthe exterior sheath is between about 20 mm and about 60 mm, such as, forexample, between about 25 mm and about 50 mm, such as between 30 mm andabout 40 mm. In certain embodiments, the delivery catheter 64 can bemoved to any of the various configurations described herein by engagingone or more actuation points 70, 71 of the delivery catheter 64.

The circular/curved planar portion 67 is advanced or lowered to lienear, on top of, or substantially on top of the plane of the mitralvalve 50. When lowered to or near the level of the annulus, the planarportion 67 or a plane of the planar portion 67 can be parallel or nearlyparallel (e.g., planar or nearly planar) with a plane of the annulus, orthe planar portion 67 can be slightly upwardly angled relative to theplane of the annulus. The delivery catheter 64 also curves to circle itsway back towards commissure A3P3. The delivery catheter 64 can be movedto create the circular/curved planar portion 67 and/or the shallowcurved portion 66 by any suitable means, such as, for example, a pullwire and ring system, or any other suitable means, including thosedescribed elsewhere in the present application. While the illustratedembodiment shows the distal end 65 being moved to create the circular orcurved planar portion 67 prior to distal end being moved to create theshallow curved portion 66, it should be understood that the downwardextension of the distal end 65 to create the shallow curved portion 66can occur prior to the distal end 65 being curved in thecounter-clockwise direction to create the circular or curved planarportion 67.

Referring to FIGS. 9G-9H, an actuation point 70 (and/or one or moreother actuation points) can be located between the shallow curvedportion 66 and the circular/curved planar portion 67 that allows thedistal section 65 to be adjusted. In the illustrated embodiment, theactuation point 70 can be adjusted to cause the planar portion 67 andthe flexible end 69 to be angled in a somewhat downward direction suchthat the flexible end 69 and distal tip 907 extend below the annulus (orbelow an upper plane of the annulus) in the direction of and/or into thecommissure A3P3 of the mitral valve 50. That is, the first actuationpoint 70 can be actuated such that the planar portion 67 (and, as aresult, the flexible end 69) is angled downward toward the commissureA3P3 and positioned at or near (e.g., extending slightly into orthrough, such as 1-5 mm or less) the commissure. Additionally oralternatively to further actuating point 70, the delivery device (e.g.,the sheath and/or delivery catheter) can be torqued or rotated to causethe angle of the circular/curved planar portion 67 to angle downwardtoward and/or into the commissure as desired. This torqueing or rotatingcan sometimes be necessary to get the angles right if the actuations ofthe curved portions does not fully position the distal region of thecatheter as desired. In some embodiments, a second actuation point 71can be located between the portion 67 and the flexible end 69.

FIG. 9I illustrates the delivery catheter 64 deploying an exemplaryembodiment of an anchoring device 1 through the commissure A3P3 andaround the chordae tendineae 62 and native leaflets in the leftventricle 52 of the patient's heart. The anchoring device 1 or a lowerend or encircling coil/turn of the anchoring device with a largerdiameter or radius of curvature exits the distal opening of the deliverycatheter 64 and begins to take its shapeset or shape memory form in thedirection of the circular or curved planar portion 67 of the deliverycatheter 64.

For the anchoring device 1 to move through the commissure A3P3 of themitral valve 50, the delivery catheter 64 is positioned such that thecircular/curved planar portion 67 and the distal opening of the flexibleend 69 of the delivery catheter 64 are angled downward, and the distalopening of the flexible end 69 is directed toward and/or into thecommissure A3P3. As a result of the circular/curved planar portion 67and the distal opening of the flexible end 69 being in a downwarddirection, the anchoring device 1 exits the delivery catheter 64 in adownward direction. After the anchoring device 1 exits the deliverycatheter 64, the anchoring device 1 begins to curve to take its shapesetor shape memory form. Because the circular/curved planar portion isangled in a downward direction, the anchoring device 1 begins to curvein an upward direction after about ½ turn of the anchoring device isdeployed, as illustrated by FIG. 9I. To prevent the anchoring device 1or lower end/encircling coil/turn from engaging the mitral valve 50 inan upward direction as it is being delivered out of the deliverycatheter 64, once the anchoring device begins to be wrapped around thechordae tendineae 62 (as shown in FIG. 9I), the delivery catheter 64 canbe moved (e.g., by moving at actuation point 70) such that thecircular/curved planar portion 67 is substantially parallel with theplane of the mitral valve 50 (see FIG. 9L). This can be done byactuating at point 70 and/or torqueing or rotating the delivery deviceor a portion thereof (e.g., the delivery catheter) to adjust the angleof the planar portion 67 as desired.

Referring to FIG. 9J, after the circular/curved planar portion 67 ismoved to be substantially planar with the mitral valve annulus, theanchoring device 1 can be further deployed from the delivery catheter64, such that the anchoring device wraps around the chordae tendineae 62in a position that is substantially parallel to the plane of the mitralvalve 50. This prevents the anchoring device from curving in an upwarddirection and engaging the underside of the mitral valve annulus and/orthe top wall of the left ventricle.

Referring to FIG. 9K, the anchoring device 1 is disposed around thechordae tendineae 62 to loosely position the anchoring device on theventricular side of the mitral valve for holding a heart valve. In theillustrated embodiment, the anchoring device 1 is disposed in the leftventricle 52 such that three functional coils 12 of the anchoring deviceare wrapped closely around the chordae tendineae and/or native leaflets.The lower end turn/coil or encircling turn/coil can be seen extendingoutwardly somewhat because of its larger radius of curvature. In someembodiments, the anchoring device 1 can include less than three coils 12or more than three coils 12 that are disposed around the chordaetendineae and/or leaflets.

FIG. 9L illustrates the delivery catheter 64 in the left atrium 51 in aposition after the coils 12 of the anchoring device are disposed aroundthe chordae tendineae 62 and native leaflets (as shown in FIG. 9K). Inthis position, the circular/curved planar portion 67 of the deliverycatheter 64 is substantially parallel with the plane of the mitral valve50 and the flexible end 69 is located at or near (e.g., extendingslightly into or through, such as 1-5 mm or less) the commissure A3P3 ofthe mitral valve 50.

Referring to FIG. 9M, after the delivery catheter 64 and the anchoringdevice 1 are positioned as shown in FIGS. 9K-9L, the delivery catheteris translated or retracted axially along the anchoring device in thedirection X and into the outer sheath 20. Translation or retracting ofthe delivery catheter can causes the portions of the anchoring devicepositioned one the atrial side of the native valve (e.g., in the atrium)to be unsheathed and released from the delivery catheter. For example,this can unsheathe and release any upper portion of any functional coiland/or upper coil positioned on the atrial side of the native valve (ifany). In one exemplary embodiment, the anchoring device 1 does not moveor does not substantially move as the delivery catheter is translated,e.g., a pusher can be used to hold the anchoring device in place and/orinhibit or prevent retraction of the anchoring device when the deliverycatheter is retracted.

Referring to FIG. 9N, in the illustrated example, translation orretraction of the delivery catheter can also unsheathe/release any upperend coil/turn (e.g., a larger diameter stabilization coil/turn) of theanchoring device 1 from the delivery catheter. As a result of theunsheathing/releasing, the atrial side of the anchoring device or uppercoil (e.g., stabilization coil with a larger diameter or radius ofcurvature) extends out of the delivery catheter 64 and begins to assumeits preset or relaxed shape-set/shape-memory shape. The anchoring devicecan also include an upward extending portion or connecting portion thatextends upward from a bend Z and can extend and/or bridge between anupper end stabilization coil/turn and other coil/turns of the anchoringdevice (e.g., functional coils/turns). In some embodiments, theanchoring device can have only one upper coil on the atrial side of thenative valve. In some embodiments, the anchoring device can include morethan one upper coil on the atrial side of the native valve.

Referring to FIG. 9O, the delivery catheter 64 continues to translateback into the outer sheath or guide sheath 20, which causes the upperportion of the anchoring device 1 to be released from inside thedelivery catheter. The anchoring device is connected closely to thepusher 950 by an attachment means, such as suture/line 901 (otherattachment or connection means can also be used, such as in FIGS.17A-18C). The upper end coil/turn or stabilization coil/turn is shown asbeing disposed along the atrial wall to temporarily and/or loosely holdthe position or height of the anchoring device 1 relative to the mitralvalve 50.

Referring to FIG. 9P, the anchoring device 1 is fully removed from alumen of the delivery catheter 64, and slack is shown in a suture/line901 that is removably attached to the anchoring device 1, e.g.,suture/line 901 can loop through an eyelet at the end of the anchoringdevice. To remove the anchoring device 1 from the delivery catheter 64,the suture 901 is removed from the anchoring device. However, before thesuture 901 is removed, the position of the anchoring device 1 can bechecked. If the position of the anchoring device 1 is incorrect, theanchoring device can be pulled back into the delivery catheter by thepusher 950 (e.g., a pusher rod, pusher wire, pusher tube, etc.) andredeployed.

Referring to FIG. 9Q, after the delivery catheter 64 and the outersheath 20 are detached from the anchoring device 1, a heart valvedelivery device/catheter 902 can be used to deliver a heart valve 903 tothe mitral valve 50. The heart valve delivery device 902 may utilize oneor more of the components of the delivery catheter 64 and/or outer orguide sheath 20 or the delivery device 902 may be independent of thedelivery catheter 64 and outer or guide sheath. In the illustratedembodiment, the heart valve delivery device 902 enters the left atrium51 using a transseptal approach.

Referring to FIG. 9R, the heart valve delivery device/catheter 902 ismoved through the mitral valve 50 such that heart valve 903 is placedbetween the leaflets of the mitral valve and the anchoring device 1. Theheart valve 903 can be guided along a guide wire 904 to the deploymentposition.

Referring to FIG. 9S, after the heart valve 903 is placed in the desiredposition, an optional balloon is expanded to expand the heart valve 903to its expanded, deployed size. That is, the optional balloon isinflated such that the heart valve 903 engages the leaflets of themitral valve 50 and forces the ventricular turns outward to an increasedsize to secure the leaflets between the heart valve 903 and theanchoring device. The outward force of the heart valve 903 and theinward force of the coil 1 can pinch the native tissue and retain theheart valve 903 and the coil to the leaflets. In some embodiments, aself-expanding heart valve can be retained in a radially compressedstate within a sheath of the heart valve delivery device 902, and theheart valve can be deployed from the sheath, which causes the heartvalve to expand to its expanded state. In some embodiments, amechanically expandable heart valve is used or a partially mechanicallyexpandable heart valve is used (e.g., a valve that may expand by acombination of self-expansion and mechanical expansion).

Referring to FIG. 9T, after the heart valve 903 is moved to its expandedstate, the heart valve delivery device 902 and the wire 904 (still shownin FIG. 9T) are removed from the patient's heart. The heart valve 903 isin a functional state and replaces the function of the mitral valve 50of the patient's heart.

FIG. 9U shows the heart valve 903 from an upward view in the leftventricle 52 along the lines U-U in FIG. 9T. In FIG. 9U, the heart valve903 is in the expanded and functional state. In the illustratedembodiment, the heart valve 903 includes three valve members 905 a-c(e.g., leaflets) that are configured to move between an open positionand a closed position. In alternative embodiments, the heart valve 903can have more than three valve members or less than three valve membersthat are configured to move between an open position and a closedposition, such as, for example, two or more valve members, three or morevalve members, four or more valve members, etc. In the illustratedembodiment, the valve members 905 a-c are shown in the closed position,which is the position the valve members are in during the systolic phaseto prevent blood from moving from the left ventricle and into the leftatrium. During the diastolic phase, the valve members 905 a-c move to anopen position, which allows blood to enter the left ventricle from theleft atrium.

While the embodiment illustrated in FIGS. 9A-9U show the deliverycatheter 64 delivering an anchoring device 1 through the commissureA3P3, it should be understood that the delivery device 64 can take aconfiguration and be positioned to deliver the anchoring device 1through the commissure A1P1, such that the anchoring device 1 can bewrapped around the chordae tendineae in the left ventricle of thepatient's heart. In addition, while the illustrated embodiments show thedelivery catheter 64 delivering an anchoring member 1 to the mitralvalve and the heart valve delivery device 902 delivering a heart valve903 to the mitral valve 50, it should be understood that the anchoringdevice 1 and the heart valve 903 can be used mutatis mutandis to repairthe tricuspid valve, the aortic valve, or the pulmonary valve.

In one embodiment, the distal section 65 of the delivery catheter 64 canbe a solid, generally cylindrical hollow tube (e.g. the distal section25″″ described in FIG. 19).

The guide sheaths and/or the distal sections of the various deliverycatheters herein can include one or multiple pull wires (e.g., 2-6 pullwires) to control or actuate the delivery catheters to desiredconfigurations. For example, distal sections of the various deliverycatheters herein can have a two-pull wire system (e.g., the two-pullwire system described in FIGS. 20A-23). For example, the configurationshown in FIGS. 9A-9U or the “hockey stick” shape configuration shown inFIG. 8 or any other configuration described in the present applicationcan also be achieved by using a flexible tube catheter constructed withtwo pull rings positioned, for example, at or near the actuation points70, 71 discussed above. The pull rings can be engaged with or connectedto respective pull wires. The pull wires can be positioned 90° away fromone another in a circumferential direction around the delivery catheter.A first pull ring that is positioned, for example, approximately halfwayalong the distal section 65, can be actuated by a first pull wire topull the distal regions of the delivery catheter onto the native valveplane (e.g., the mitral plane), while a second pull ring positionedfurther distally, at or near the distal tip 907 of the deliverycatheter, can be actuated by another pull wire to make the cathetercurve in a different direction, for example, around the native valveplane (e.g., around the mitral plane) and towards a desired commissure(e.g., the mitral commissure A3P3) and further, if necessary.

In some embodiments, the two pull rings can be connected by a spine thatis implemented on a radially opposite side of one of the pull wires, forexample, opposite the pull wire for the distalmost pull ring. Such anadded spine can restrict the relative movement between the pull rings,and help to better control the direction of deflection caused by pullingthe pull wire for the distalmost pull ring, and preventing deflection ofthe flexible distal section in a direction perpendicular to the mitralplane, or in otherwise unintended directions. While the embodimentdescribed above can include three pull rings and two pull wires, itshould be understood that any number of pull rings and/or pull wires canbe used to create the various configurations described herein. Inaddition, it should be understood that any suitable number of spines canbe used to restrict the relative movement between the pull rings

In some embodiments, the distal section 65 can be a laser cut hypotube(similar to the laser cut catheters described in FIGS. 4-7 above),arranged in a pattern such that, when bent, the distal section forms anyof the various configurations described herein (e.g., the configurationsdescribed in FIGS. 9A-9U, the “hockey stick configuration, etc.). Alsoas discussed, such laser cut distal section can have two or moreactuation points that can be actuated independent from one another, forexample, with separate pull wires that are, for example, controlled byseparate controls (e.g., knobs, tabs, inputs, buttons, levers, switches,etc.) or other mechanisms, in order to effectuate the dual directionaldeflections in the distal end in the fully bent configuration (e.g., theone curve being towards the mitral plane, and the other curve being thecircular portion that curves generally around the mitral annulus).

In some embodiments, the entire distal section 65 does not need to beconstructed as a laser cut hypotube. For example, the distal section 65can include a first flexible straight section proximal to the shallowcurved portion 66, an optional small laser cut elbow portion making upthe shallow curved portion 66 to help bend the distalmost regions of thecatheter onto the mitral plane, and then a second flexible sectionextending to the distal tip with the ability to curve along the mitralplane so as to point the end of the catheter towards commissure A3P3.The first flexible section allows the distal section 65 to get near themitral plane after exiting the transseptal sheath 20, and is flexibleenough to be pushed and advanced through the sheath 20, but still rigidenough to resist being affected by the anchoring device when theanchoring device is being advanced and delivered through the catheter.The first flexible section can be constructed, for example, with apolyether block amide (PEBAX) having a hardness of approximately SOD,that is coated over a coiled or braided tube. Meanwhile, the small lasercut elbow portion can have a maximum deflection of approximately 150° toassist in bringing the distal regions of the catheter onto the mitralplane. Lastly, the second flexible section can extend to the distal tipof the delivery catheter, and be configured to flex to point thecatheter towards commissure A3P3, as well as to potentially flex furtherto assist with chordae encircling by the anchoring device, similarly ashas already been discussed above. The second flexible section can alsobe constructed, for example, with PEBAX, with for example a hardness ofapproximately SSD, and that is also reflowed over a coiled or braidedtube. Using this configuration can still yield a distal section 65 thatcan be shaped and actuated substantially similarly to the laser cuthypotube discussed above, without the need to form the entire distalsection 65 as a laser cut hypotube, or any portion from a laser cuthypotube.

While the delivery catheter 64 having a distal section 65 is describedusing the embodiments described above, it should be understood that theembodiment described above are only exemplary. The delivery catheter 64can take any suitable form that is capable of creating the shapeconfigurations described herein. In addition, the delivery catheter canbe constructed with any suitable material that is capable of creatingthe shape configurations described herein.

FIG. 10 shows a perspective view of an exemplary distal section 75 of adelivery catheter 74 (which can be the same as or similar to otherdelivery catheters described herein) for implanting an anchoring device(which can be the same as or similar to other anchoring devicesdescribed herein) at a native valve. For the mitral valve, this can bedone using a transseptal technique. The delivery catheter is shown asassuming an example of a spiral configuration. Unlike the “hockey stick”configuration, and similar to the configuration discussed in FIGS.9A-9U, the sheath 20 extends through the FO in a direction parallel tothe plane of the native valve annulus (e.g., the mitral plane). In thisembodiment, the distal section 75 then exits the sheath 20 and extendsfor approximately one spiral down to commissure A3P3 of the mitralvalve. The distal section 75 can be shape set with a spiral where thedistal end of the catheter can initially extend below the native valveannulus plane during deployment. The user can then adjust the height ofthe distal end, for example, by applying an upward tension on a flexwire integrated into or attached to the catheter, to bring the distalend up to or just above the native valve annulus plane of the patient'sheart.

In some embodiments, the distal section 75 can be a full laser cuthypotube (similar to the laser cut catheter described in FIGS. 4-7above) where the cuts are arranged in a pattern such that, when bent,the distal section forms the spiral configuration. In some embodiments,the spiral configuration of the laser cut hypotube is allowed to beshape set to a spiral that stretches or extends to the native valveannulus plane (e.g., that stretches or extends from the FO to a positionthat is lower than the mitral plane). Respective gaps between the topteeth and their associated slots (e.g., where the slots are radiallywider than the teeth to provide a space for the teeth to move radiallywhen they are in their respective slots) allows the vertical stretchingof the catheter to occur. The distal section can be shape set with thisvertically stretched configuration. Then when the spiral is in themitral anatomy, the distal tip of the catheter can be pulled up toposition it along or just above the mitral plane, for example, byflexing or tensioning the flex wire in or otherwise attached to thedistal section of the catheter as previously discussed. This featureallows the spiral to be adjusted to varying heights to accommodatedifferent patient anatomies.

In another embodiment employing the delivery catheter 74 with the spiralconfiguration, the distal section 75 may not be constructed as a lasercut hypotube, but can instead be formed as a coated coil. For example,the catheter can be formed by a braided or coiled tube with a lowdurometer PEBAX with a hardness of about 55D, for example, coated overit. When flexed, the catheter can make a spiral configuration similarlyas discussed above. Meanwhile, to control the height of the spiral, apusher wire can be included that runs along the shaft of the deliverycatheter and optionally connects to the distal end of the catheter. Thepusher wire has sufficient strength and physical properties to allow thedistal end of the catheter to be pushed and/or pulled onto the nativevalve annulus plane (e.g., the mitral plane). For example, the pusherwire can be a NiTi wire, a steel, or any other suitable wire. In oneembodiment, pushing the pusher wire will lower the distal end of thespiral, and pulling back on the pusher wire will raise the distal end ofthe delivery catheter, in case the distal end goes below the nativevalve annulus plane (e.g., below the mitral plane).

In another embodiment employing the delivery catheter 74 with the spiralconfiguration, the distal section may not be laser cut or otherwise cutat all (e.g., similar to the distal section 25″″ shown in FIG. 19). Forexample, the distal section 75 of the delivery catheter 74 can be formedby a flexible tube catheter constructed with pull rings, pull wires,and/or spines configured to move the delivery catheter 74 into thespiral configuration.

While the delivery catheter 74 having a distal section 75 is describedusing the embodiments described above, it should be understood that theembodiments described above are only exemplary. The delivery catheter 74can take any suitable form that is capable of creating the spiralconfiguration. In addition, the delivery catheter can be constructedwith any suitable material that is capable of creating the spiralconfiguration (e.g., the distal section 75 can take the form of thedelivery catheter 114 shown in FIGS. 20A-23).

FIG. 11 shows a perspective view of a hybrid configuration of a distalsection 105 of a delivery catheter 104. The delivery catheter 104combines features from both the “hockey stick” and the spiralconfigurations discussed above. In the hybrid configuration, similar tothe “hockey stick” configuration, the distal section 105 of the deliverycatheter 104 first has a shallow curved or bent portion 106 to bend thecatheter 104 towards the mitral plane. In an alternative embodiment, thecatheter 104 is bent by increasing the proximal flex of the bent portion106. The shallow curved portion can be followed by a circular or curvedplanar portion 107 that begins curving, for example, in acounter-clockwise direction as shown. In other embodiments, the deliverycatheter 104 can instead bend or curve in a clockwise direction (e.g.,as seen in FIG. 8). The planar portion 107 can be substantially parallelto the mitral plane.

Meanwhile, distal to the planar portion 107 is a flexible end portion108 that can be bent, angled, or otherwise pointed slightly downwardsout of the plane in which the planar portion 107 is arranged, to moreeffectively point the distal opening of the delivery catheter 104towards or through a commissure or other target. In some embodiments,the flexible end portion 108 can form a downwardly spiraling region ofthe delivery catheter 104. The flexible end portion 108 can be deflectedor displaced from the planar portion 107 by, for example, between about2 mm and about 10 mm in a vertical direction, such as between about 3 mmand about 9 mm, such as between about 4 mm and about 8 mm, such asbetween about 5 mm and about 7 mm, such as about 6 mm. In otherembodiments, the vertical displacement can be about 2 mm or more, suchas about 3 mm or more, such as about 4 mm or more, such as about 5 mm ormore, such as about 6 mm or more, such as about 7 mm or more, such asabout 8 mm or more, such as about 9 mm or more, such as about 10 mm.Furthermore, in some embodiments, the flexible end portion 108 (i.e.,the downward spiraling section) can begin substantially from the curvedportion 106, such that there is only a small portion, or even noportion, of the distal section 105 of the delivery catheter 104 thatextends in a plane substantially parallel to the mitral plane.

Like the previously described delivery catheters, the distal section 105of the delivery catheter 104 can be made of or include a laser cuthypotube, a braided or coiled tube catheter, a flexible tube having nocuts, or other flexible tubular construction. In some embodiments, thedistal section 105 of the catheter 104 can be coated, for example, withPEBAX. Furthermore, the distal end 105 of the delivery catheter 104 canbe actuated or manipulated, for example, via shape setting, pull wiresand/or pull rings, spines, and/or utilizing various other ways orfeatures described in the present application.

Meanwhile, while in the above described embodiments, the delivery deviceis generally or mostly positioned above the native valve annulus plane(e.g., mitral plane), and the anchoring device is extruded from thedelivery device while still on the atrial side or just slightly beyondit ((e.g., 1-5 mm or less), and advanced into the ventricle (forexample, through a commissure of the native valve), in some otherembodiments, at least a portion or a substantial portion of the deliverydevice itself can also be positioned in the left ventricle. For example,FIG. 12 shows a delivery device for installing an anchoring device 1 ata native mitral valve using a transseptal technique, where much of thedistal end of the delivery device itself (e.g., the curved portion oractuatable portion) is also advanced through the native mitral valve andinto the left ventricle.

Referring to FIG. 12, the delivery device shown includes an outer guidesheath 20 and a flexible delivery catheter 114 that can be advancedthrough and out of a distal end of the guide sheath 20. In theembodiment shown, the guide sheath 20 can first be steered, for exampleas seen in FIG. 12, through an opening that is formed in the interatrialseptum (e.g., at the fossa ovalis), and into the left atrium. The guidesheath 20 can then be manipulated to curve or bend downwards towards thenative mitral valve annulus, so that the distal opening of the guidesheath 20 points substantially coaxially with a central axis of themitral annulus. A vertical position of the guide sheath 20 can be suchthat the distal opening of the guide sheath 20 is substantially alignedwith the native mitral annulus, or can be positioned in the left atriumslightly above the native mitral annulus, or, in some embodiments (asshown in FIG. 12), can extend through the native mitral annulus and intothe left ventricle.

Once the guide sheath 20 is positioned substantially as shown in FIG.12, the delivery catheter 114 is then advanced out of the distal openingof the guide sheath 20. In this embodiment, the distal end of the guidesheath 20 is positioned at or slightly above the native mitral annulus,so that the delivery catheter 114 can first be advanced into the leftatrium, just above the native mitral annulus. The delivery catheter 114can initially be advanced out of the distal opening of the guide sheath20 in an unactuated, substantially straight configuration, and canthereafter be actuated into the bent configuration shown in FIG. 12after advancement out of the guide sheath 20. In some embodiments, thedelivery catheter 114 can be actuated to any other suitableconfiguration, such as, for example, any configuration described in thepresent application.

The flexible delivery catheter 114 can include two main deflectablesections or more, e.g., a distal section 115 that is bendable into acurved configuration that is relatively wider and more circular in shapefor assisting in shaping the anchoring device 1 when the anchoringdevice 1 is advanced out of the delivery catheter 114 and delivered tothe implant site, and a more proximal section 116 that forms a sharperbent portion, for example, a bend of approximately 90 degrees, to assistin bringing the distal section 115 into a plane that is substantiallycoplanar with or parallel to the native annulus plane (e.g., the mitralplane). The delivery catheter 114 can take any suitable form, such as,for example, any form described in the present application.

Referring to FIGS. 13-16, in one exemplary embodiment, a distal region117 of an exemplary delivery catheter 114 can be constructed of ahypotube having a first series of slots 125 and a second series of slots126. The delivery catheter can also have a pull wire system (e.g., a twopull wire system that includes a first pull wire 135 and a second pullwire 136). FIG. 13 shows a schematic side view of a distal section 117of an exemplary embodiment of a delivery catheter 114. FIG. 14 shows across-sectional view of a multi-lumen extrusion portion of the deliverycatheter 114, the cross-section taken in a plane perpendicular to alongitudinal axis of the delivery catheter, and FIGS. 15 and 16respectively show schematic perspective views of the delivery catheter114 of FIG. 13 in partial and fully actuated states. Other deliverycatheters that are deployed and used in different manners, for example,as shown in any of the embodiments discussed above, can also beconstructed in a similar two pull wire system.

In one embodiment, the delivery catheter 114 has a distal region 117including two flexible sections 115, 116. A first series of slots 125can be arranged (e.g., linearly arranged or otherwise) along a firstside of the distal region 117, corresponding and providing flexibilityto the first flexible section 115, so that the first flexible section115 can form a generally circular configuration (e.g., which can besimilar to that shown in FIG. 12) when the delivery catheter isactuated. A second series of slots 126 can be arranged linearly along asecond side of the distal region 117, corresponding and providingflexibility to the second flexible section 116, so that the secondflexible section 116 can form the sharper bend shown in FIG. 12 when thedelivery catheter 114 is actuated. The slots 125, 126 can be laser cutor formed similarly as discussed in previous embodiments, or canotherwise be formed in various other manners, so long as the slots 125,126 contribute to the desired shaping of the delivery catheter 114 uponactuation. The second series of slots 126 is positioned slightlyproximal to the first series of slots 125 corresponding to the bendingpositions of the sections 115, 116, and can be offset in acircumferential direction, for example, by approximately 90 degreesaround the distal region 117, in order to allow for two orthogonal bendsin the region, where the respective radii of curvature and directions ofarticulation of the sections 115, 116 can be different from one another.In some embodiments, the section 115, 116 can be offset in acircumferential direction by, for example, between about 65 degrees andabout 115 degrees, such as between about 75 degrees and about 105degrees, such as between about 80 degrees and about 100 degrees, such asbetween about 85 degrees and about 95 degrees.

In certain embodiments, each of the sections 115, 116 can have anassociated pull wire 135, 136, for respectively controlling the bendingof the sections 115, 116. The pull wire 135 can extend distally past theslots 125 and can be attached to the distal region 117, for example, viawelding or other attachment means at connection point 135 a and/or apull ring. Similarly, the pull wire 136 can extend distally past theslots 126 and can be welded or otherwise attached to the distal region117 at connection point 136 a and/or a pull ring.

Meanwhile, on a proximal side of the distal region 117, the deliverycatheter 114 can include a proximal section 140 that can be formed as abraided multi-lumen tube extrusion. As can be seen in the cross-sectionof FIG. 14, the proximal section 140 of the delivery catheter 114 canhave one or more central lumens through which the pull wires 135, 136extend to reach the distal region 117. The pull wires 135, 136 can bearranged to extend side-by-side through a central region of proximalsection 140, and can then exit distally from the proximal section 140and attached to the side walls of the distal region 117, as previouslydescribed. The central positioning of the pull wires 135, 136 throughthe proximal section 140 provides for an anti-whipping or anti-bendingeffect through the delivery catheter 114 when the pull wires 135, 136are used, allowing the delivery catheter 114 to maintain fulltorqueability. However, in some embodiments, the pull wires are notcentrally positioned, but run along the side walls or outer walls fromend to end.

In addition, the proximal section 140 can have a main lumen 141. Wherethe pull wires are not centered, the main lumen can be centered.Optionally, main lumen 141 can be offset from the center of theextrusion, e.g., when the pull wires are centered. The main lumen 141 issufficiently sized for an anchoring device to pass and be deliveredtherethrough. The main lumen 141 can have, for example, an ovoidcross-section, a circular cross-section, or can have a cross-sectionwith any other appropriate shape, so long as the anchoring device 1 canbe effectively advanced through it. In addition to the main lumen, anumber of optional parallel dummy lumens can also be formed in andextend longitudinally through the proximal section 140, e.g., in orderto affect a symmetric moment of inertia about the pull wires through theproximal section 140. In the embodiment shown, a first dummy lumen 142is optionally positioned diametrically opposite the main delivery lumen141 and is formed to be substantially the same shape as the main lumen141 (e.g., ovoid in the illustrated embodiment). In addition, two moreoptional dummy lumens 143 are positioned diametrically opposite oneanother and circumferentially between the lumens 141 and 142. Theadditional dummy lumens 143 are illustrated to be slightly smaller thanthe lumens 141, 142, and have a more circular shape. In practice, thesize and shape of the dummy lumens 143 can otherwise vary, and willgenerally be selected based on the respective sizes of the lumens 141,142, and the amount of space remaining in the extrusion. In addition,the main lumen 141 and the first dummy lumen 142 can also have variablesizes and shapes, depending on the particular application. Furthermore,in some other embodiments, more or less than four total lumens can beformed in the proximal section 140, to affect a desired symmetry andmoment of inertia, and to even out the stiffness, about the pull wiresthat run through the center axis of the proximal section 140.

Referring back to FIGS. 2B, 9A-9N, and 12, in practice, once the guidesheath 20 is arranged or positioned as desired (e.g., as shown ordescribed elsewhere herein, for example, crossing the septum in a mitralprocedure, distal regions of the delivery catheter (e.g., distal region117 or any of the other distal regions described herein), and in someembodiments, a portion of a proximal section (e.g., proximal section140), are advanced out of the distal opening of the guide sheath 20. Theportions of the delivery catheter (e.g., catheter 114) that extend outof the guide sheath 20 can be positioned in the left atrium before thedelivery catheter is adjusted to its actuated configuration or finalactuated configuration. In some cases, part of the delivery catheter canalso extend (e.g., as in FIG. 12 or with just the tip extendingslightly, such as 1-5 mm or less) into the left ventricle through thenative mitral valve before the delivery catheter is adjusted to itsactuated configuration or final actuated configuration. The pull wires135, 136 can then be tensioned in order to actuate the distal region 117and to gain articulation of the two bends, e.g., in sections 115, 116,at the distal portions of the delivery catheter 114. For example, in onesequence, as shown in FIG. 15, the second pull wire 136 can first betensioned in order to bend section 116 and bring the portions of thedelivery catheter 114 distal to section 116 substantially planar and/orparallel to the native annulus. Then, as shown in FIG. 16, the firstpull wire 135 can then be tensioned, to bend section 115 to its roundedor curved actuated state, such that the curvature of section 115 issubstantially planar to and/or parallel with the native valve annulus(e.g., with the mitral plane). In other embodiments, the pull wires 135,136 can be tensioned partially or fully in different amounts and/ororders to properly and safely navigate around the patient's anatomyduring actuation. For example, section 115 can be actuated and curved toform a circular or curved planar portion (e.g., similar to planarportion 67) before actuating or curving section 116 to lower and/orproperly angle the curved planar portion or section 115 (e.g., asdescribed with respect to FIG. 9). After these actuating steps, in oneembodiment, the distal region 117 of the delivery catheter 114 can befully or mostly positioned in the left atrium, or on the atrial side ofthe native valve.

In some circumstances, actuation of the curved regions of the deliverycatheter may not alone be enough to properly position the distal tip ator near the commissure in a desired position for delivery, and torqueingor rotating the delivery device or a portion thereof (e.g., rotating thedelivery catheter and/or guide sheath) can be used to angle the deliverycatheter and a tip of the delivery catheter as desired. For example,after the distal region 117 of the delivery catheter 114 is fullyactuated or curved as desired (e.g., as described above), the assemblycan be torqued and rotated to cause the tip of the delivery catheter 114to be angled or aligned at or into a commissure of the native valve, forexample, at commissure A3P3 of the mitral valve. The delivery catheter114 can then be further torqued and rotated so that the distal tip ofthe delivery catheter 114 passes through the commissure and into theleft ventricle. Optionally, further rotation and/or actuation of thedelivery catheter 114 can then facilitate circumferential advancement ofthe distal tip of the delivery catheter 114 in the left ventricle, to belooped or positioned around an outside of the mitral anatomy, forexample, chordae tendineae, papillary muscles, and/or other features inthe left ventricle. The design of the proximal section 140 and thecentral arrangement of the pull wires 135, 136 helps provide for ananti-whipping or anti-bending effect through the delivery catheter 114when the pull wires 135, 136 are operated, allows for maintaining offull torqueability of the delivery catheter 114 through the transseptalbend, and facilitates the actuated shape of the distal region 117 to beheld and maintained more effectively during this rotation step.

Referring to FIG. 12, if a user elects to move the distal region of thecatheter into a ventricle (e.g., left or right ventricle), movement ofthe delivery catheter 114 around the anatomy in the ventricle can serveto gather or capture the corralled anatomy within the bend of the distalregion 117. In some embodiments, after the distal region 117 of thedelivery catheter 114 is moved to a desired position around the chordaeand other features in the ventricle, the first pull wire 135 can stillbe tensioned further, in order to reduce the radius of curvature of therounded section 115, in order to cinch and gather the chordae and othernative anatomy passing through the center of the rounded section 115even further towards the center of the native annulus. Such radialcinching or gathering of the native anatomy in the ventricle can helpfacilitate an even more robust delivery of the anchoring device 1 later,for example, by making it easier for the anchoring device 1 to beadvanced around the gathered chordae and other features.

After the delivery catheter 114 has been satisfactorily positionedaround the chordae and other desired anatomy in the left ventricle, theanchoring device 1 can be advanced out of the distal opening of thedelivery catheter 114. The curved shape of the rounded section 115 canfacilitate smoother and easier extrusion of the anchoring device 1 fromthe delivery catheter 114, since the curvature of the rounded section115 can be formed to be substantially similar to the final curvature ofthe anchoring device 1. Furthermore, the initial looping of the distalregion 117 around at least part of the desired mitral anatomy in theleft ventricle can facilitate easier delivery of the anchoring device 1outside and around the same anatomy that has already been corralled.Once the ventricular portion of the anchoring device 1 has been advancedto a desired position in the left ventricle, the atrial portion of theanchoring device 1 can be released from the delivery catheter 114 in asimilar manner as one of the various ways discussed above, for example,by backwards axial translation of the delivery catheter 114. Suchtranslation of the delivery catheter 114 can also help retract thedelivery catheter 114 itself out of the left ventricle and back into theleft atrium. Then, after the anchoring device 1 has been fully deliveredand moved to a desired position, the tensioning in the pull wires 135,136 can be released, and the delivery catheter 114 can be straightenedand retracted back through the guide sheath 20. Thereafter, a prosthesis(e.g., a THV or other prosthetic valve) can be advanced to and expandedin the anchoring device 1, similarly as previously discussed.

FIGS. 20A-20E, 22 and 23 illustrate an exemplary embodiment of adelivery catheter that can operate in the same or similar manner as thedelivery catheters 64, 114 described above. Any of the components,mechanisms, functions, elements, etc. (e.g., the steering or actuationmechanism or pull wire system, pull wires, rings, spines, etc.) of thisembodiment can be incorporated into other delivery catheters (and evenguide sheaths) described herein. In the example illustrated by FIGS.20A-20E, 22, and 23, the distal region 117 of the delivery catheter 114can be constructed of flexible tube 2030 (e.g., which can be the same asor similar to the flexible tube 25″″ shown in FIG. 19 or other tubesdescribed herein). The delivery catheter has a steering/actuationmechanism or pull wire system that can be used to actuate and curve thedistal region of the catheter. A steering/actuation mechanism or pullwire system herein can have one or more pull wires (e.g., 1-6 or morepull wires), one or more rings or pull rings (e.g., 1-7 or more rings),one or more spines, and/or other components.

In the illustrated embodiment, the delivery catheter has a two pull wiresystem that includes a first pull wire 2035, a second pull wire 2036,three rings or pull rings (i.e., a first ring 2037, a second ring 2038,a third ring 2039), a first spine 2040, and a second spine 2041. FIG.20A shows an end view of a distal section 117 of the delivery catheter114. FIG. 20C is a sectional view of the delivery catheter 114 of FIG.20A taken along the plane indicated by lines C-C. FIG. 20B is asectional view of the delivery catheter 114 taken along the planeindicated by lines B-B. FIG. 20D shows a cross sectional view of thedelivery catheter 114 taken along the plane indicated by lines D-D inFIG. 20A. FIG. 20E is taken along the plane indicated by across-sectional view of the delivery catheter 114 taken along the planeindicated by lines E-E in FIG. 20A. FIGS. 21A and 21B are schematicperspective views of the delivery catheter 114 in partially and fullyactuated states, respectively, similar to the views of FIGS. 15 and 16.FIG. 22A is a partial view of the delivery catheter 114. FIGS. 22B-22Dshow cross-sectional views of the delivery catheter taken along theplanes indicated by lines B-B, C-C, and D-D, respectively, in FIG. 22A.FIG. 23 is a side view of the two-pull wire system for the deliverycatheter 114. Other delivery catheters or sheaths that are deployed andused in different manners, for example, as shown in any of theembodiments discussed above, can also be constructed with a similar twopull wire system. While the illustrated embodiments show the deliverycatheter 114 having rings 2037, 2038, 2039 and spines 2040, 2041, itshould be understood that the delivery catheter 114 can be constructedhaving any number of rings and/or spines, or without any rings orspines.

In the illustrated embodiment, the delivery catheter 114 has a distalregion 117 including the two flexible sections 115, 116. Referring toFIG. 20C, the first flexible section 115 extends between the first ring2037 and the second ring 2038. A first pull wire 2035 is attached to thefirst ring 2037 at connection point A, and actuation of the first pullwire 2035 causes the first flexible section 115 to form the generallycircular configuration shown in FIGS. 11 and 12. Referring to FIGS. 20Cand 20D and 22A and 22B, an optional spine 2040 is connected between thefirst ring 2037 and the second ring 2038. The spine 2040 is made of astiffer material than the flexible tube 2030 and, therefore, isconfigured to restrict the movement, such as compression, of between therings 2037, 2038 when the first pull wire 2035 is actuated. The spine2040 can be made of, for example, stainless steel, plastic, or any othersuitable material that is stiffer than the flexible tube. The flexibletube 2030 can be made out of, for example, nitinol, steel, and/orplastic, or any other suitable material or combination of materials thatallow the delivery catheter 114 to be moved to a flexed configuration(e.g., the flexed configuration shown in FIG. 12). In certainembodiments, the ratio of Shore D hardness for the spine 2040 to Shore Dhardness of the flexible tube 2030 is between about 3:1. In certainembodiments the, ratio of shore D hardness of the spine 2040 to theflexible tube 2030 is between about 1.5:1 and about 5:1, such as betweenabout 2:1 and about 4:1, such as between about 2.5:1 and about 3.5:1. Inalternative embodiments, the ratio of Shore D hardness of the spine 2040to the flexible tube 2030 is greater than 5:1 or less than 1.5:1.

In the illustrated embodiment, the spine 2040 is disposed substantiallyopposite the first pull wire 2035 such that a center of the spine 2040is circumferentially offset from the first pull wire 2035 byapproximately 180 degrees. A center of the spine 2040 can becircumferentially offset from the first pull wire 2035 by between about70 degrees and about 110 degrees, such as between about 80 degrees andabout 100 degrees, such as between about 85 degrees and about 95degrees. Referring to FIG. 22B, the width of the spine 2040 (defined bythe angle θ) can be any suitable width that allows the delivery catheter114 to move to the bent configuration shown in FIGS. 11 and 12. Incertain embodiments, the angle between the edges 2201, 2203 of the spine2040 can between about 45 degrees and about 135 degrees, such as betweenabout 60 degrees and about 120 degrees, such as between about 75 degreesand about 105 degrees such as between about 85 degrees and 95 degrees,such as about 90 degrees. A larger angle θ allows for the spine 2040 tohave more control in restricting the movement of the rings 2037, 2038 ascompared to a smaller angle θ. The spine 2041 can be made of, forexample, nitinol, steel, and/or plastic, or any other suitable materialor combination of materials.

Referring to FIG. 20B, the second flexible section 116 extends betweenthe second ring 2038 and the third ring 2039. The second pull wire 2036is attached to the second ring 2038 at connection point B, and actuationof the second pull wire 2036 causes the second flexible section 116 toform the sharper bend shown in FIGS. 11 and 12. Referring to FIGS. 20Band 20E and 22A and 22C, an optional spine 2041 is connected between thesecond ring 2038 and the third ring 2039. The spine 2041 is made of astiffer material than the flexible tube 2030 and, therefore, isconfigured to restrict the movement of between the rings 2038, 2039 whenthe second pull wire 2036 is actuated. The spine 2041 can be made of,for example, stainless steel, plastic, or any other suitable materialthat is stiffer than the flexible tube. The flexible tube 2030 can bemade out of, for example, nitinol, steel, and/or plastic, or any othersuitable material or combination of materials that allow the deliverycatheter 114 to be moved to a flexed configuration (e.g., the flexedconfiguration shown in FIG. 12). In certain embodiments, the ratio ofShore D hardness for the spine 2041 to Shore D hardness of the flexibletube 2030 is between about 3:1. In certain embodiments the, ratio ofshore D hardness of the spine 2041 to the flexible tube 2030 is betweenabout 1.5:1 and about 5:1, such as between about 2:1 and about 4:1, suchas between about 2.5:1 and about 3.5:1. In alternative embodiments, theratio of Shore D hardness of the spine 2041 to the flexible tube 2030 isgreater than 5:1 or less than 1.5:1.

In the illustrated embodiment, the spine 2041 is disposed substantiallyopposite the second pull wire 2036 such that a center of the spine 2041is circumferentially offset from the second pull wire 2036 byapproximately 180 degrees. A center of the spine 2041 can becircumferentially offset from the second pull wire 2036 by between about70 degrees and about 110 degrees, such as between about 80 degrees andabout 100 degrees, such as between about 85 degrees and about 95degrees. Referring to FIG. 22C, the width of the spine 2041 (defined bythe angle β) can be any suitable width that allows the delivery catheter114 to move to the bent configuration shown in FIG. 12. In certainembodiments, the angle β between the edges 2205, 2207 of the spine 2041can between about 45 degrees and about 135 degrees, such as betweenabout 60 degrees and about 120 degrees, such as between about 75 degreesand about 105 degrees such as between about 85 degrees and 95 degrees,such as about 90 degrees. A larger angle β allows for the spine 2040 tohave more control (i.e. add more stiffness) in restricting the movementof the rings 2037, 2038 as compared to a smaller angle β.

Referring to FIGS. 20D and 20E, the delivery catheter 114 includes alumen 2032 that is sufficiently sized for delivering an anchoring device1 therethrough, and the lumen 2032 remains sufficiently sized fordelivering the anchoring device 1 when the first pull wire 2035 and thesecond pull wire 2036 are actuated to move the delivery catheter 114 tothe bent configuration shown in FIG. 12. The lumen 2032 can have, forexample, an ovoid cross-section, a circular cross-section, or can have across-section with any other appropriate shape, so long as the anchoringdevice 1 can be effectively advanced through it.

The connection point B for attaching the second pull wire 2036 to thesecond ring 2038 is positioned proximal to the connection point A forattaching the first pull wire 2035 to the first ring 2037 and can beoffset in a circumferential direction, for example, by approximately 90degrees around the distal region 117. A 90 degree offset allows for twoorthogonal bends in the region, where the respective radii of curvatureand directions of articulation of the sections 115, 116 can be differentfrom one another and independent from one another. In some embodiments,the section 115, 116 can be offset in a circumferential direction by,for example, between about 65 degrees and about 115 degrees, such asbetween about 75 degrees and about 105 degrees, such as between about 80degrees and about 100 degrees, such as between about 85 degrees andabout 95 degrees. Referring to FIGS. 20C and 20E, in certainembodiments, the wires 2035, 2036 run along a length L of the deliverycatheter 114 such that the wires are substantially parallel to an axis Xthat extends through a center of the delivery catheter. In thisembodiment, the wires 2035, 2036 are offset in a circumferentialdirection such that an angle α between the wires 2035, 2036 is betweenabout 65 degrees and about 115 degrees, such as between about 75 degreesand about 105 degrees, such as between about 80 degrees and about 100degrees, such as between about 85 degrees and about 95 degrees, such asabout 90 degrees.

Referring to FIGS. 9A-9U and 20A-23, in practice, once the guide sheath20 is arranged approximate the native valve annulus (e.g., the mitralannulus or tricuspid annulus), for example, at the position shown,distal regions of the delivery catheter 114, including distal region 117(and in some embodiments, a portion of proximal section 2034) areadvanced out of the distal opening of the guide sheath 20. Here, theportions of the delivery catheter 114 that extend out of the guidesheath 20 can be positioned in an atrium (e.g., left or right atrium),while in some cases, part of the delivery catheter 114 can also extendslightly (e.g., 1-5 mm or less) into a ventricle (e.g., left or rightventricle) through the native valve (e.g., native mitral valve) or acommissure of the native valve before the delivery catheter 114 isadjusted to its actuated configuration or, if partially actuatedpreviously, to its full or final actuated configuration. The pull wires2035, 2036 can then be tensioned in order to actuate the distal region117 and to gain articulation of the two bends in sections 115, 116 atthe distal portions of the delivery catheter 114. For example, in onesequence, as shown in FIG. 21A, the second pull wire 2036 can first betensioned in order to bend section 116 and bring the portions of thedelivery catheter 114 distal to section 116 substantially planar to thenative annulus (e.g., native mitral annulus). Then, as shown in FIG.21B, the first pull wire 2035 can then be tensioned, to bend section 115to its rounded or curved actuated state, such that the curvature ofsection 115 is substantially planar to or parallel with a plane of thenative valve annulus (e.g., the mitral plane). In other embodiments, thepull wires 2035, 2036 can be tensioned partially or fully in differentamounts and/or orders to properly and safely navigate around or relativeto the patient's anatomy during actuation. For example, the pull wires2035, 2036 can be tensioned to move the delivery catheter 114 in thesame manner that the delivery catheter 64 moved in FIGS. 9A-9U.Actuation of the pull wires or pull wire system can be used incombination with torqueing or rotating the delivery device or a portionthere (e.g., the delivery catheter or sheath) to direct the distalregion and distal tip of the catheter to a desired position and/ororientation.

For example, after the distal region 117 of the delivery catheter 114 isfully actuated or actuated to a desired configuration (as shown in FIG.21B), the assembly can then be torqued and rotated so that the tip ofthe delivery catheter 114 is aligned at a commissure of the native valve(e.g., of the native mitral valve, for example, at commissure A3P3). Thedelivery catheter 114 can be torqued and rotated so that the distal tipof the delivery catheter 114 is directed toward and/or directed into thecommissure. Further rotation of the delivery catheter 114 can thenfacilitate circumferential advancement of the distal tip of the deliverycatheter 114 toward and/or into the commissure, and/or to changedirection from a downward direction to a more even or parallel (or lessdownward) direction (e.g., after a first end of the anchoring device hasbeen pushed or extruded out of the delivery catheter) so the end of theanchoring device does not come up undesirably after insertion and hit orpush against the underside of the valve annulus, such that the anchoringdevice 1 can be looped or positioned around an outside of the nativeanatomy (e.g., outside of the native mitral anatomy), for example,chordae tendineae, papillary muscles, and/or other features in theventricle.

Referring to FIGS. 22A-22D and 23, in certain embodiments, the deliverycatheter 114 includes a first conduit 2210 (e.g., a tube, sleeve, etc.)for housing the first pull wire 2035 a second conduit 2212 for housingthe second pull wire 2036. In the illustrated embodiment, the conduits2210, 2212 are defined, at least in part, by a liner 2215 and an innersurface 2216 of the flexible tube 2030. In some embodiments, theconduits 2210, 2212 can take any other suitable form. In someembodiments, conduits are not used to house the pull wires 2035, 2036.The design of the proximal section 140 and the arrangement of the pullwires 2035, 2036 provide for an anti-whipping or anti-bending effectthrough the delivery catheter 114 when the pull wires 135, 136 areoperated. This can allow for maintaining full torqueability of thedelivery catheter 114 through the transseptal bend. This can alsofacilitate the actuated shape of the distal region 117 to be held andmaintained more effectively during torqueing or rotation duringdelivery. In some embodiments, the delivery catheter 114 includes afirst coil sleeve 2211 that extends around the first pull wire 2035until it reaches the first flexing section 115 and a second coil sleeve2213 that extends around the second pull wire 2036 until it reaches thesecond flexing section 116. The coil sleeves 2211, 2213 are configuredto provide for the anti-whipping or anti-bending effect and formaintaining the full torqueability of the delivery catheter 114.

Deployment of the delivery device 1 from the delivery catheter 114 (and,optionally, movement of the delivery catheter 114 around the anatomy inthe ventricle) serves to gather or capture the corralled anatomy withinthe anchoring device 1. In some embodiments, the distal region 117 ofthe delivery catheter 114 is moved to a desired position around thechordae and other features in the left ventricle, and the first pullwire 135 is tensioned in order to reduce the radius of curvature of therounded section 115, and in order to cinch and gather the chordae andother mitral anatomy passing through the center of the rounded section115 even further towards the center of the native annulus. Such radialcinching or gathering of the mitral anatomy in the left ventricle canhelp facilitate an even more robust delivery of the anchoring device 1later, for example, by making it easier for the anchoring device 1 to beadvanced around the gathered chordae and other features.

When the delivery catheter is used in the ventricle to corral nativeanatomy, after the delivery catheter 114 has been satisfactorilypositioned around the chordae and other desired anatomy in the leftventricle, the anchoring device 1 can be advanced out of the distalopening of the delivery catheter 114. The curved shape of the roundedsection 115 can facilitate smoother and easier extrusion of theanchoring device 1 from the delivery catheter 114, since the curvatureof the rounded section 115 can be formed to be substantially similar tothe final curvature of the anchoring device 1. Furthermore, the initiallooping of the distal region 117 around at least part of the desiredmitral anatomy in the left ventricle facilitates easier delivery of theanchoring device 1 outside and around the same anatomy that has alreadybeen corralled. Once the ventricular portion of the anchoring device 1has been advanced to a desired position in the left ventricle, theatrial portion of the anchoring device 1 can be released from thedelivery catheter 114 in a similar manner as one of the various waysdiscussed above, for example, by backwards axial translation of thedelivery catheter 114. Such translation of the delivery catheter 114 canalso help retract the delivery catheter 114 itself out of the leftventricle and back into the left atrium. Then, after the anchoringdevice 1 has been fully delivered and moved to a desired position, thetensioning in the pull wires 2035, 2036 can be released, and thedelivery catheter 114 can be straightened and retracted back through theguide sheath 20. Thereafter, a THV or other prosthetic valve can beadvanced to and expanded in the anchoring device 1, similarly aspreviously discussed.

In some embodiments (e.g., any of the embodiments for a deliverycatheters described in the present application), an atraumatic tip 118can also be formed at the end of the distal region 117, to prevent orreduce potential damage to the guide sheath 20 or the patient's anatomywhen the delivery catheter 114 is advanced and maneuvered to its desiredposition and orientation. The atraumatic tip 118 can be an extension ofthe distal region 117 that is formed in a rounded or otherwiseatraumatic shape, or can, for example, be an added layer that is formedfrom a different material from the distal region 117, for example, anadditional braided layer and/or be made from a lower durometer material.

Optionally, the anchoring or docking device can also include alow-friction sleeve, e.g., a PTFE sleeve, that fits around all or aportion (e.g., the leading and/or functional turns) of the anchoring ordocking device. For example, the low-friction sleeve can include a lumenin which the anchoring device (or a portion thereof) fits. Thelow-friction sleeve can make it easier to slide and/or rotate theanchoring device into position as it exits the delivery catheter withless-friction and being less likely to cause abrasions or damage to thenative tissue than the surface of the anchoring device. The low-frictionsleeve can be removable (e.g., by pulling proximally on the sleeve whileholding a pusher and the anchoring device in place) after the anchoringdevice is in position in the native valve, e.g., to expose the surfaceof the anchoring device, which can be or include portions configured(porous, braided, large surface area, etc.) to promote tissue ingrowth.

The delivery catheter configurations described herein provide exampleembodiments that allow for accurate positioning and deployment of ananchoring device. However, in some instances, retrieval or partialretrieval of the anchoring device can still be necessary at any stageduring or after deployment of the anchoring device in order, forexample, to reposition the anchoring device at the native valve, or toremove the anchoring device from the implant site. The below embodimentsdescribe various locks or lock-release mechanisms that can be used forattaching and/or detaching an anchoring or docking device from adeployment pusher that pushes the anchoring device out of the deliverycatheter. Other locks or locking mechanisms are also possible, e.g., asdescribed in U.S. Provisional Patent Application Ser. No. 62/560,962,filed on Sep. 20, 2017 incorporated by reference herein. The anchoringdevice can be connected at its proximal side to a pusher or othermechanism that can push, pull, and easily detach from the anchoringdevice.

In previous examples, a suture or line of the pusher or pusher toolpasses through an opening or eyelet in the end of the anchoring deviceto hold the anchoring device and allow retrievability and release of theanchoring device. FIGS. 17A-17C show perspective views of a proximal end82 of an exemplary anchoring device 81 and a ball locker or lockingmechanism 84. The anchoring device 81 can be similar to the anchoringdevice embodiments described above, with the addition of the modifiedproximal end 82, as seen in FIG. 17A. The proximal end 82 of theanchoring device 81 has an elongate tube structure 83 that forms alocking tube, and the ball locking mechanism 84 includes a pusher 85(which can be the same as or similar to other pushers herein mutatismutandis) and a pull wire 86 that interact with the locking tube 83. Thepusher 85 includes a flexible tube 87 which, although shown cut away inFIGS. 17A-17C, can be long enough to extend through the deliverycatheter during deployment of the anchoring device 81. The pull wire 86extends through the pusher 85 and can protrude through a distal end ofthe pusher 85 with a length that allows the pull wire 86 to also gothrough the locking tube 83 of the anchoring device 81. The pusher 85has a distal tip 88 and a short wire 89 connected to and/or extendingfrom the pusher tip 88. A distal end of the short wire 89 includes aspherical ball 90.

The locking tube 83 at the proximal end 82 of the anchoring device 81 issized to receive the spherical ball 90 of the short wire 89therethrough, as shown in FIG. 17B. The locking tube 83 is a short tubethat can be welded to or otherwise affixed to a proximal end of theanchoring device 81 (as oriented during delivery). The internal diameterof the locking tube 83 is slightly greater than the external diameter ofthe spherical ball 90, so that the ball 90 can pass therethrough. Thelock or locking mechanism is based on the relative diameters of theinner diameter of the locking tube 83, the diameter of the ball 90, andthe diameters of the other portions of the short wire 89 and of the pullwire 86.

After the ball 90 passes through and out of the distal end of thelocking tube 83, locking can be achieved by preventing the ball 90 frompassing back through and being released from the locking tube 83. Thiscan be accomplished by also inserting the pull wire 86 into the lockingtube 83. When both the thinner portion of the short wire 89 and the pullwire 86 are threaded and positioned in the locking tube 83, as shown inFIGS. 17C-17D, the ball 90 is blocked from passing back through thelocking tube 83, and thereby locking the anchoring device 81 to thepusher 85. As best seen in FIG. 17D, when the pull wire 86 is in thelocking tube 83, the pull wire 86 blocks the short wire 89 from movingto a more central position in the bore of the locking tube 83,preventing the ball 90 from aligning with and retracting back outthrough the locking tube 83. Therefore, the ball 90 abuts against adistal end of the locking tube 83 when the pusher 85 is pulledproximally therefrom. In this locked position, the pusher 85 is lockedto the anchoring device 81 and the pusher 85 can push or pull theanchoring device 81 to more accurately position the anchoring device 81during surgery. Only upon pulling the pull wire 86 back out of thelocking tube 83 is there a clear path and sufficient space for the ball90 to be aligned with and released from the locking tube 83 and for theanchoring device 81 to be unlocked or disconnected from the pusher 85.Meanwhile, retracting the pull wire 86 to unlock the anchoring device 81requires only a relatively small pull force, since the locking forcerelies mainly on the short wire 89, which takes most of the load whenthe mechanism is locked.

The pull wire 86 also need only travel a short distance to be removedfrom the locking tube 83. For example, unlocking the anchoring device 81from the pusher 85 may only involve retracting the pull wire 86 by about10 mm to remove the pull wire 86 from the locking tube 83 and to allowthe spherical ball 90 to be released. In other embodiments, theanchoring device 81 may be unlocked from the pusher 85 by retracting thepull wire 86 by between about 6 mm and about 14 mm, such as betweenabout 7 mm and about 13 mm, such as between about 8 mm and about 12 mm,such as between about 9 mm and about 11 mm. In certain embodiments, theanchoring device 81 may be unlocked from the pusher 85 by retracting thepull wire 86 less than 6 mm or more than 14 mm. The embodiment of FIGS.17A-17D provides a robust and reliable locking mechanism which canachieve a strong locking force, while at the same time only needing asmall pull force to unlock and detach the components from one another.

In use, the ball locking mechanism 84 can be assembled with theanchoring device 81, for example, as seen in FIG. 17C, prior toimplantation. After a distal section of a delivery catheter ispositioned at or near a native valve annulus, for example, at a mitralvalve annulus, using one of the techniques described with respect toFIGS. 8, 9A-9U, and 10 above, the pusher 85 can push the anchoringdevice 81 through the delivery catheter to deploy the anchoring device81. The user can then use the pusher 85 to further retract and/oradvance the anchoring device 81 at the native valve annulus in order tomore accurately position the anchoring device 81 at the implant site.Once the anchoring device 81 is accurately positioned, the pull wire 86can be retracted from the locking tube 83, as shown in FIG. 17B, and thespherical ball 90 can then also be retracted and released from thelocking tube 83, as shown in FIG. 17A, thereby detaching the anchoringdevice 81 from the ball locking mechanism 84. The pusher 85 can then beremoved from the implant site.

FIGS. 18A-18C show perspective views of a proximal end 92 of ananchoring device 91 and a loop locking mechanism 94, according to anembodiment of the invention. The anchoring device 91 can be similar tothe anchoring device embodiments described above, with the addition ofthe modified proximal end 92, as seen in FIG. 18A. The proximal end 92of the anchoring device 91 has an elongate proximal hole or slot 93, andthe loop locking mechanism 94 includes a pusher 95 and a side wire orpull wire 96 that interact with the hole 93. The pusher 95 includes aflexible tube 97 which can be long enough to extend through the deliverycatheter during deployment of the anchoring device 91. The pull wire 96extends through the pusher 95 and can protrude through the distal end ofthe pusher 95 with a length that allows the pull wire 96 to engage awire loop 99, as discussed in greater detail below. The pusher 95 has adistal tip 98 and a wire loop 99 connected to and/or extending from thepusher tip 98. In this embodiment, the loop 99 extends distally from thedistal tip 98 of the pusher 95, and has a distalmost loop portion thatextends perpendicularly to a longitudinal axis of the pusher 95,generally. While in this embodiment the wire loop 99 is shown as being awire, such as a cylindrical metal wire, the invention is not so limited.In other embodiments, the loop 99 can also be made, for example, from aflat piece of metal or other material that is laser cut, can be formedby using a suture, or can take any other suitable form that is capableof entering slot 93 of the anchoring device 91 and receiving pull wire96 to secure the anchoring device 91 to the pusher 95.

The hole 93 at the proximal end 92 of the anchoring device 91 is sizedto receive the end of the wire loop 99, as shown in FIG. 18B. When thewire loop 99 is threaded and passed through the hole 93, an end of thewire loop 99 extends out past an opposite side of the hole 93, such thatthe loop 99 is exposed or protrudes from the opposite side. The loop 99should be able to protrude from the opposite side of the hole 93 by anamount that is sufficient to allow the pull wire 96 to be inserted orthreaded through the loop 99, as shown in FIG. 18C. Then, by passing thepull wire 96 through the loop 99, as shown in FIG. 18C, the anchoringdevice 91 can attach to or engage the pusher 95 in a locked position,where the pusher 95 can push or pull the anchoring device 91 to moreaccurately position the anchoring device 91 during surgery. In thislocked position, the pull wire 96 anchors the loop 99 in position andprevents the loop 99 from being retracted back out of the hole 93. Onlyupon pulling the pull wire 96 back out of the loop 99 can the loop 99 bedetached from the hole 93 and for the anchoring device 91 to be unlockedor disconnected from the pusher 95. Meanwhile, retracting the pull wire96 to unlock the anchoring device 91 requires only a relatively smallpull force, since the locking force relies mainly on the loop 99, whichtakes most of the load when the mechanism is locked.

The loop locking mechanism 94 relies on the interaction between the loop99 of the pusher 95 and the pull wire 96. Therefore, the loop 99 shouldhave a length that is, on one hand, long or tall enough to protrude froma side of the hole 93 opposite the side of insertion to leave sufficientroom for the pull wire 96 to be passed through and on the other hand,short enough to reduce vertical shifting when locked, in order tomaintain a tight connection between the pusher 95 and the anchoringdevice 91. Therefore, the embodiment in FIGS. 18A-18C also provide arobust and reliable locking mechanism which can achieve a strong lockingforce, while also only needing a small pull force and a small amount ofretraction by the pull wire 96 for unlocking the components. Forexample, unlocking the anchoring device 91 from the pusher 95 may onlyinvolve retracting the pull wire 96 by about 10 mm to remove the pullwire 96 from the loop 99 and to allow the loop 99 to be released. Inother embodiments, the anchoring device 91 may be unlocked from thepusher 95 by retracting the pull wire 96 by between about 6 mm and about14 mm, such as between about 7 mm and about 13 mm, such as between about8 mm and about 12 mm, such as between about 9 mm and about 11 mm. Incertain embodiments, the anchoring device 91 may be unlocked from thepusher 95 by retracting the pull wire 86 less than 6 mm or more than 14mm

In use, the loop locking mechanism 94 can be assembled with theanchoring device 91, as seen in FIG. 18C, prior to surgery. After adistal section of a delivery catheter is positioned at or near a nativevalve annulus, for example, at a mitral valve annulus, using one of thetechniques described with respect to FIGS. 8, 9A-9U, and 10 above, thepusher 95 can push the anchoring device 91 through the delivery catheterto deploy the anchoring device 91. The user can then use the pusher 95to further retract and/or advance the anchoring device 91 at the nativevalve annulus in order to more accurately position the anchoring device91 at the implant site. Once the anchoring device 91 is accuratelypositioned, the pull wire 96 can be retracted out of the loop 99, asshown in FIG. 18B, and the loop 99 can then be retracted out of the hole93, as shown in FIG. 18A, thereby detaching the anchoring device 91 fromthe loop locking mechanism 94. The pusher 95 can then be removed fromthe implant site.

Additional pushers and retrieval devices and other systems, devices,components, methods, etc. are disclosed in U.S. provisional patentapplication Ser. No. 62/436,695, filed on Dec. 20, 2016 and U.S.Provisional Patent Application Ser. No. 62/560,962, filed on Sep. 20,2017 and the related PCT Patent Application Serial No. PCT/US2017/066865titled “SYSTEMS AND MECHANISMS FOR DEPLOYING A DOCKING DEVICE FOR AREPLACEMENT HEART VALVE” filed on Dec. 15, 2017 (that claims priority tothe foregoing provisional applications) each of the foregoingapplications is incorporated herein by reference in its entirety. Any ofthe embodiments and methods disclosed in the foregoing applications canbe used with any of the embodiments and methods disclosed by the presentapplication mutatis mutandis.

The various manipulations and controls of the systems and devicesdescribed herein can be automated and/or motorized. For example, thecontrols or knobs described above can be buttons or electrical inputsthat cause the actions described with respect to the controls/knobsabove. This can be done by connecting (directly or indirectly) some orall of the moving parts to a motor (e.g., an electrical motor, pneumaticmotor, hydraulic motor, etc.) that is actuated by the buttons orelectrical inputs. For example, the motor can be configured, whenactuated, to cause the control wires or pull wires described herein totension or relax to move the distal region of the catheter. Additionallyor alternatively, the motor could configured, when actuated, to causethe pusher to move translationally or axially relative to the catheterto cause an anchoring or docking device to move within and/or into orout of the catheter. Automatic stops or preventative measures could bebuilt in to prevent damage to the system/device and/or patient, e.g., toprevent movement of a component beyond a certain point.

It should be noted that the devices and apparatuses described herein canbe used with other surgical procedures and access points (e.g.,transapical, open heart, etc.). It should also be noted that the devicesdescribed herein (e.g., the deployment tools) can also be used incombination with various other types of anchoring devices and/orprosthetic valves different from the examples described herein.

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatuses, and systems should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The methods, apparatuses, and systems are not limited toany specific aspect or feature or combination thereof, nor do thedisclosed embodiments require that any one or more specific advantagesbe present or problems be solved. Features, elements, or components ofone embodiment can be combined into other embodiments herein.

Although the operations of some of the disclosed embodiments aredescribed in a particular, sequential order for convenient presentation,it should be understood that this manner of description encompassesrearrangement, unless a particular ordering is required by specificlanguage. For example, operations described sequentially can in somecases be rearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods can be used in conjunction with other methods.Additionally, the description sometimes uses terms like “provide” or“achieve” to describe the disclosed methods. These terms are high-levelabstractions of the actual operations that are performed. The actualoperations that correspond to these terms can vary depending on theparticular implementation and are readily discernible by one of ordinaryskill in the art. Steps of various methods herein can be combined.

In view of the many possible embodiments to which the principles of thedisclosure can be applied, it should be recognized that the illustratedembodiments are only preferred examples of the invention and should notbe taken as limiting the scope of the disclosure. Rather, the scope ofthe disclosure is defined by the following claims.

What is claimed is:
 1. A delivery catheter for delivering a device to anative valve of a patient's heart, comprising: a flexible tube having amain lumen and a control wire lumen; a plurality of links disposed inthe distal region of the flexible tube; wherein each link is alignedwith and connected to at least one adjacent link with a slot formedbetween each pair of adjacent links; and wherein a top portion of eachlink is narrower than a bottom portion of each link when the links areviewed from a side; and a control wire in the control wire conduit thatis connected to the plurality of links; wherein applying tension to thecontrol wire causes the distal region of the flexible tube to bend. 2.The delivery catheter of claim 1 wherein each link is connected to atleast one adjacent link only at a bottom portion of the links.
 3. Thedelivery catheter of claim Error! Reference source not found. whereinthe top portions of the links are drawn closer together when tension isapplied to the control wire to bend the distal region.
 4. The deliverycatheter of claim 1 wherein when the plurality of links are in astraight configuration when tension is removed from the control wire. 5.The delivery catheter of claim 1 wherein the flexible tube furthercomprises a polymer coating.
 6. The delivery catheter of claim 1 whereinthe flexible tube further comprises a polyether block amide coating. 7.The delivery catheter of claim 1 wherein the plurality of links arecomprised of at least one of a shape memory material, stainless steel,or a polymer.
 8. The delivery catheter of claim 1, wherein a bottom ofeach link includes at least one slit slits to allow for more flexing ofthe links relative to one another.
 9. The delivery catheter of claim 1wherein the control wire is moveably coupled to the second anchor ring.10. The delivery catheter of claim 1 wherein the links are cut from asingle tube.
 11. The delivery catheter of claim 1 wherein the links arecut from a single flat sheet of material that is rolled to form thelinks.
 12. The delivery catheter of claim 1 wherein the control wireextends distally past the links and is attached to the distal section bya ring.
 13. The delivery catheter of claim 1 further comprising: a firstring in a distal region of the flexible tube; and a second ring in thedistal region of the flexible tube that is spaced apart from the firstring; wherein the plurality of links are disposed in the distal regionof the flexible tube between the first ring and the second ring;
 14. Thedelivery catheter of claim 1 further comprising a coil sleeve disposedin the control wire lumen around the control wire.
 15. The deliverycatheter of claim 0 wherein the coil sleeve extends proximally from thedistal region of the flexible tube such that a portion of the controlwire that extends from the second ring and to the first ring is notcovered by the coil sleeve.
 16. A delivery catheter for delivering adevice to a native valve of a patient's heart, comprising: a flexibletube having a main lumen and a control wire lumen; a first ring in adistal region of the flexible tube; a second ring in the distal regionof the flexible tube that is spaced apart from the first ring; a controlwire in the control wire conduit that is connected to the first ring; aplurality of links disposed in the distal region of the flexible tubebetween the first ring and the second ring; and a coil sleeve disposedin the control wire lumen around the control wire; wherein the coilsleeve extends proximally from the distal region of the flexible tubesuch that a portion of the control wire that extends from the secondring and to the first ring is not covered by the coil sleeve; andwherein applying tension to the control wire causes the distal region ofthe flexible tube to bend.
 17. The delivery catheter of claim 0 whereineach link is connected to at least one adjacent link only at a bottomportion of the links.
 18. The delivery catheter of claim 0 a top portionof each link is narrower than a bottom portion of each link when thelinks are viewed from a side.
 19. The delivery catheter of claim 18wherein the top portions of the links are drawn closer together whentension is applied to the control wire to bend the distal region. 20.The delivery catheter of claim 0 wherein when the plurality of links arein a straight configuration when tension is removed from the controlwire.
 21. The delivery catheter of claim 0 wherein the flexible tubefurther comprises a polymer coating.
 22. The delivery catheter of claim0 wherein the flexible tube further comprises a polyether block amidecoating.
 23. The delivery catheter of claim 0 wherein the plurality oflinks are comprised of at least one of a shape memory material,stainless steel, or a polymer.
 24. The delivery catheter of claim 0,wherein a bottom of each link includes at least one slit to allow formore flexing of the links relative to one another.
 25. The deliverycatheter of claim 0 wherein the control wire is moveably coupled to thesecond anchor ring.
 26. The delivery catheter of claim 0 wherein theplurality of links are cut from a single tube, such that each link isaligned with and connected to at least one adjacent link with a slotformed between each pair of adjacent links.
 27. The delivery catheter ofclaim 0 wherein the plurality of links are cut from a single flat sheetand rolled, such that each link is aligned with and connected to atleast one adjacent link with a slot formed between each pair of adjacentlinks.
 28. The delivery catheter of claim 0 wherein the pull wire canextend distally past the links and can be attached to the distal sectionby welding or other attachment means at least at one connection point inthe distal section.
 29. A delivery catheter for delivering a device to anative valve of a patient's heart, comprising: a flexible tube having acentered main lumen and a control wire lumen; a first ring in a distalregion of the flexible tube; a second ring in the distal region of theflexible tube that is spaced apart from the first ring; a control wirein the control wire conduit that is connected to the first ring; aplurality of links disposed in the distal region of the flexible tubebetween the first ring and the second ring; wherein the plurality ofcylindrically shaped links that are cut from a single piece of material,such that each link is aligned with and connected to at least oneadjacent link with a slot formed between each pair of adjacent links;and a coil sleeve disposed in the control wire lumen around the controlwire; wherein the coil sleeve extends proximally from the distal regionof the flexible tube such that a portion of the control wire thatextends from the second ring and to the first ring is not covered by thecoil sleeve; and wherein applying tension to the control wire causes thedistal region of the flexible tube to bend.
 30. The delivery catheter ofclaim 29 wherein each link is connected to at least one adjacent linkonly at a bottom portion of the links.
 31. The delivery catheter ofclaim 29 a top portion of each link is narrower than a bottom portion ofeach link when the links are viewed from a side.
 32. The deliverycatheter of claim 31 wherein the top portions of the links are drawncloser together when tension is applied to the control wire to bend thedistal region.
 33. The delivery catheter of claim 29 wherein when theplurality of links are in a straight configuration when tension isremoved from the control wire.
 34. The delivery catheter of claim 29wherein the flexible tube further comprises a polymer coating.
 35. Thedelivery catheter of claim 29 wherein the flexible tube furthercomprises a polyether block amide coating.
 36. The delivery catheter ofclaim 29 wherein the plurality of links are comprised of at least one ofa shape memory material, stainless steel, or a polymer.
 37. The deliverycatheter of claim 29, wherein a bottom of each link includes at leastone slit slits to allow for more flexing of the links relative to oneanother.
 38. The delivery catheter of claim 29 the control wire ismoveably coupled to the second anchor ring.
 39. The delivery catheter ofclaim 29 wherein the links are cut from a single tube.
 40. The deliverycatheter of claim 29 wherein the links are cut from a single flat sheetof material that is rolled to form the links.
 41. The delivery catheterof claim 29 wherein the pull wire can extend distally past the links andcan be attached to the distal section by welding or other attachmentmeans at least at one connection point in the distal section.
 42. Thedelivery catheter of claim 29 wherein the pull wire can be attached toan anchor ring positioned at or distal to the first end.
 43. A sheet forforming into a flexible catheter tube, the sheet comprising: a flatsheet; and a plurality of spaced apart aligned cutouts each having acentral portion between two end portions, wherein a width of the centralportion of each cutout is wider than the width of the two end portionsof each cutout; wherein the cutouts form a corresponding plurality ofspaced apart aligned strips each having a central portion and two endportions; wherein a width of the central portion of strip is narrowerthan the width of the two end portions of strip; and wherein the sheetis configured to be rolled into a substantially cylindrical shape havinga plurality of links with a slot formed between each pair of adjacentlinks, wherein top portions of the links correspond to the centralportions of the strips and bottom portions of the links correspond tothe end portions of the strips.
 44. The sheet of claim 43 where thesheet is made from a shape memory material.
 45. The sheet of claim 43wherein the cutouts are laser cut.
 46. A method of making a flexiblecatheter tube, the sheet comprising: providing a flat sheet; cutting aplurality of spaced apart aligned cutouts in to the sheet, each cutouthaving a central portion between two end portions, wherein a width ofthe central portion of each cutout is wider than the width of the twoend portions of each cutout and wherein the cutouts form a correspondingplurality of spaced apart aligned strips each having a central portionand two end portions; wherein a width of the central portion of strip isnarrower than the width of the two end portions of strip; and rollingthe sheet into a substantially cylindrical shape having a plurality oflinks with a slot formed between each pair of adjacent links, whereintop portions of the links correspond to the central portions of thestrips and bottom portions of the links correspond to the end portionsof the strips.
 47. The sheet of claim 43 wherein the sheet is made froma shape memory material.
 48. The sheet of claim 43 wherein the cutoutsare laser cut.